Adherence

National Guideline Centre (UK)

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Adherence

Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s

Evidence review N

NICE Guideline, No. 202

Authors

National Guideline Centre (UK).

London: National Institute for Health and Care Excellence (NICE); 2021 Aug.

ISBN-13: 978-1-4731-4229-9

1. Adherence

1.1. Review question: What support improves adherence to CPAP or other interventions?

1.2. Introduction

Adherence to interventions such as CPAP/non-invasive ventilation/oral devices/positional modifiers for obstructive sleep apnoea/hypopnoea syndrome (OSAHS), obesity hypoventilation syndrome (OHS) or COPD-OSAHS overlap syndrome is essential in order for these interventions to be effective. Optimal adherence to CPAP therapy is conventionally considered to be four or more hours per night or use for an average of more than 4 hours per night for 70% or more nights. There is some evidence suggesting that increased CPAP use of more than 5 hours a night in OSAHS benefits other aspects of health such as control of blood pressure and cardiovascular risk. However, it is recognised that use of CPAP for four hours per night or more is an arbitrary figure not based on good quality evidence and that people can gain some benefit from a shorter period of use. People should be encouraged to maximise their CPAP use to achieve optimal control of their symptoms, underlying conditions, sleep quality and quality of life. Adherence to other devices is thought to be equally important to gain any benefit.

An evidence review was conducted to assess interventions designed to inform participants about improving adherence of CPAP/non-invasive ventilation, positional modifiers and oral devices, to support them in using these interventions and to modify their behaviour in improving their use.

1.3. PICO table

For full details see the review protocol in appendix A.

1.4. Clinical evidence

1.4.1. Included studies

OSAHS

CPAP

Total of 46 studies reviewing educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea were included in the review. This included one Cochrane review⁵ with 41 studies and 5 additional studies identified in re-runs¹²^,³⁴^,⁴³^,⁵⁷^,⁶¹ these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).

Studies were categorised into the following comparisons:

Behavioural vs. Control - interventions employing psychotherapeutic techniques deriving from behavioural, cognitive or cognitive-behavioural models of health behaviour change (e.g., specific models within this broad genre include motivational enhancement therapy [Miller], Transtheoretical/Stages of Change Model [Prochaska and DiClemente], CBT [Beck]). By definition, behavioural interventions under any of these related models involves at least a minimal degree of direct participant engagement or interaction (as opposed to purely educational, in which information is merely imparted to participants, even if the educational content or style of presentation was based on a cognitive/behavioural model). The objectives of such interventions included enhancing motivation for change, self-efficacy, outcome expectations and/or decisional balance in favour of CPAP. There were a broad range of interventions included in this category such as myofunctional therapy, progressive muscle relaxation training, audiotaped music along with softly spoken directions on relaxation techniques and habit-promoting instructions for using CPAP nightly, motivational interviewing, one to one sessions with a clinical psychologist, motivational enhancement which is devised on the principles of motivational interviewing, motivational enhancement therapy and telephone-linked communications.
Educational vs. Control – interventions imparting information about CPAP treatment or about OSAHS more generally, delivered through video format, face-to-face didactic sessions, group educational sessions, written materials, or any combination of these. Interventions that did not involve a component of active engagement from the participants other than reading written materials or observing a presentation or demonstration, even if the content derived from a behavioural change model, were classified as educational.
Supportive vs. Control - interventions in which participants were provided with additional clinical follow-up (e.g., additional office or home-based visits or phone check-ins by clinical staff) or with telemonitoring equipment that facilitated self-monitoring of CPAP usage or that facilitated monitoring by clinical staff to prompt as needed clinical follow-up (e.g., a phone call made to participants when CPAP usage fell below a predetermined threshold) for the purpose of addressing barriers or difficulties with CPAP usage in a timely manner (e.g. telemedicine systems, digitised phone calls or audio messages, and/or home visits)
Mixed vs. Control – interventions that combined elements of the three previously listed intervention-types (e.g. educational video and material provided + telemedicine follow-up)

In cases where studies used a mixed combination of intervention-types (behavioural, educational or supportive), but had multiple active intervention arms that had distinct elements of one type of intervention (e.g. intervention 1 supportive vs. intervention 2 educational vs. control), the active interventions groups were separated and included in the appropriate comparison subcategory for meta-analysis.

Studies had people with moderate and severe OSAHS; however, the majority of the studies were in people with severe sleep apnoea.

No evidence was identified for the critical outcome mortality.

Oral devices

No studies identified educational, supportive and behavioural interventions to improve usage of oral devices in adults with obstructive sleep apnoea, OHS and COPD-OSAHS overlap syndrome.

Positional modifiers

No studies identified educational, supportive and behavioural interventions to improve usage of positional modifiers in adults with obstructive sleep apnoea, obstructive sleep apnoea/OHS and COPD-OSAHS overlap syndrome.

OHS

No evidence identified for improving adherence of CPAP and non-invasive ventilation (NIV) in OHS.

COPD-OSAHS overlap syndrome

No evidence identified for improving adherence of CPAP and non-invasive ventilation (NIV) in COPD-OSAHS overlap syndrome.

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

1.4.2. Excluded studies

See the excluded studies list in appendix H.

1.4.3. Summary of clinical studies included in the evidence review

See appendix D for full evidence tables.

1.4.4. Quality assessment of clinical studies included in the evidence review

See appendix F for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

No health economic studies were included.

1.5.2. Excluded studies

No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in appendix G.

1.5.3. Health economic modelling

Original modelling was not prioritised for this question.

1.5.4. Health economic evidence statements

No relevant economic evaluations were identified.

1.6. The committee’s discussion of the evidence

1.6.1. Interpreting the evidence

1.6.1.1. The outcomes that matter most

The committee considered the outcomes of proportion adherent >4hrs/night for CPAP/non-invasive ventilation, adherence in hours/night for CPAP and oral devices, self-reported adherence, quality of life and mortality as critical outcomes for decision making. Other important outcomes included , sleepiness scores (e.g. Epworth), apnoea-Hypopnoea index (AHI) or respiratory disturbance index, oxygen desaturation index , mood or anxiety, withdrawals, treatment related withdrawals, CO₂ control, minor adverse effects of treatment, driving outcomes, neurocognitive outcomes and impact on co-existing conditions:HbA1c for diabetes, cardiovascular events for cardiovascular disease and systolic blood pressure for hypertension.

No evidence was identified for the outcomes of mortality, mood or anxiety, neurocognitive outcomes and impact on co-existing conditions: HbA1c for diabetes, cardiovascular events for cardiovascular disease and systolic blood pressure for hypertension for the OSAHS population.

1.6.1.2. The quality of the evidence

OSAHS

CPAP

The quality of the evidence for interventions to improve usage of CPAP in adults with OSAHS varied from moderate to very low quality; majority of the evidence was downgraded due to risk of bias, inconsistency, indirectness and imprecision. Risk of bias was most commonly due to selection bias. Studies were downgraded for indirectness if they included mixed severity OSAHS. The committee also acknowledged that some uncertainty existed across the effect sizes seen within the evidence, with some confidence intervals crossing the MID thresholds or line of no effect. The committee took into account the quality of the evidence, including the uncertainty in their interpretation of the evidence.

The committee considered the clinical importance for AHI on a case by case basis, taking into consideration the baseline AHI and the improvement in severity of sleep apnoea.

There was evidence from 46 studies evaluating educational, supportive and behavioural interventions to improve use of continuous positive airway pressure in adults with obstructive sleep apnoea. Interventions in the review were classified as: educational interventions, behavioural interventions, supportive interventions and mixed interventions. There was a huge variation in the specific type of interventions used in all the categories.

Educational interventions included imparting information about CPAP treatment or about OSAHS more generally, delivered through video format, face-to-face didactic sessions, group educational sessions, written materials, or any combination of these.

There were a broad range of behavioural interventions, with a huge variation in the type (motivational interviewing, oropharyngeal exercises, audio tape with CPAP information and relaxation techniques), delivery (by psychologists, nurses/nurse counsellors) and timing of interventions (after the first session of CPAP/1 week after CPAP/1 month after CPAP).

Supportive interventions included where participants were provided with additional clinical follow-up (e.g. additional office or home-based visits, video or phone check-ins by clinical staff) or with telemonitoring equipment that facilitated self-monitoring of CPAP usage or that facilitated monitoring by clinical staff to prompt ‘as needed’ clinical follow-up.

Mixed interventions combined elements of the three previously listed intervention-types.

Most of the studies included people who are new to CPAP, and there was very little evidence available on people who have difficulty using CPAP. Studies included people with moderate and severe OSAHS.

The committee recognised the lack of evidence in people with mild sleep apnoea and in people who have difficulty using CPAP.

Positional modifiers

There was no evidence for educational, supportive and behavioural interventions to improve usage of positional modifiers in adults with OSAHS.

Oral devices

There was no evidence for educational, supportive and behavioural interventions to improve usage of oral devices in adults with OSAHS.

OHS

No evidence was identified for improving adherence of CPAP and non-invasive ventilation (NIV) in OHS.

COPD-OSAHS overlap syndrome

No evidence was identified for improving adherence of CPAP and non-invasive ventilation (NIV) in COPD-OSAHS overlap syndrome.

1.6.1.3. Benefits and harms

OSAHS

CPAP

Behavioural therapy + CPAP versus control + CPAP

The evidence suggested that there was clinically important benefit with behavioural therapy + CPAP compared to control + CPAP for the outcomes CPAP device usage (hours/night) and number of participants deemed adherent (≥ four hours/night), although there was some uncertainty around the effect estimates. The evidence suggested that there was no clinically important difference between behavioural therapy + CPAP and control + CPAP for the outcomes of withdrawal, Epworth Sleepiness Scale, AHI on treatment, and quality of life.

Educational interventions + CPAP versus usual care + CPAP

The evidence suggested that there was clinically important benefit with educational interventions + CPAP compared to usual care + CPAP for the outcomes CPAP device usage (hours/night) and number of participants deemed adherent (≥ four hours/night), although there was some uncertainty around the effect estimates. The evidence suggested that there was no clinically important difference between educational interventions + CPAP and usual care + CPAP for the outcomes of withdrawal and Epworth Sleepiness Scale.

Increased practical support and encouragement during follow-up + CPAP versus usual care + CPAP

The evidence suggested that there was clinically important benefit with supportive interventions + CPAP compared to control + CPAP for the outcomes CPAP device usage (hours/night) , , number of participants deemed adherent (≥ four hours/night), mean adherence all days (min per day) , days CPAP used > 4 hours at 3 months and systolic and diastolic blood pressure, although there was some uncertainty around the effect estimates. The evidence suggested that there was no clinically important difference between supportive interventions + CPAP and control + CPAP for the outcomes of days CPAP used > 4 hours at 12 months, CPAP use (min/night), withdrawal, Epworth Sleepiness Scale, AHI on treatment. The evidence for quality was life was inconsistent, with no difference between supportive interventions + CPAP and control + CPAP for quality of life scales SF-36, SAQLI, FOSQ and benefit for increased practical support for quality life FOSQ-10.

Mixed (educational/supportive/behavioural) intervention + CPAP versus usual care + CPAP

The evidence suggested that there was clinically important benefit with mixed interventions + CPAP compared to control + CPAP for the outcomes CPAP device usage (hours/night) and number of participants deemed adherent (≥ four hours/night), although there was some uncertainty around the effect estimates. The evidence suggested that there was no clinically important difference between mixed interventions + CPAP and control + CPAP for the outcomes of withdrawal, Epworth Sleepiness Scale, and AHI on treatment. The evidence for quality was life was inconsistent, with no difference between mixed interventions + CPAP and control + CPAP for quality of life scale FOSQ and benefit for mixed interventions for quality life FOSQ-10 and SF-36 (physical health).

Interventions to improve adherence of interventions for OSAHS- committee’s consideration of the evidence

The overall evidence suggested that all types of interventions (educational, behavioural, supportive and mixed) increased CPAP usage to varying degrees in CPAP‐naive participants with moderate to severe OSAHS. However, it was unclear from the evidence whether any of these interventions also led to meaningful improvement of daytime symptoms or quality of life. There was no evidence of harm associated with these interventions. Although there was uncertainty around the effect estimates for some of the outcomes, the committee agreed that the direction of effect on the whole was positive and the evidence base was large enough to justify a recommendation. The evidence did not show which category of interventions is best suited for individual patients. Also, optimum duration/intensity and long‐term effectiveness of these interventions were not clear from the evidence. However, the committee did not make a research recommendation on this as they did not consider it to be a priority for research recommendation.

In current practice some form of educational interventions is offered, however the content and delivery of these interventions is not consistent across all centers.

Based on the evidence and their knowledge of current practice, the committee agreed that educational or supportive interventions or a combination of these, provided by specialist staff, would help to improve adherence to CPAP. Educational interventions include providing information about OSAHS, its treatment and outcomes, which can be delivered using a variety of different sessions and formats, whereas supportive interventions involve additional clinical follow-up (for example, extra clinic visits, teleconsultations, video consultations or use of telemonitoring) to provide support. Due to the lack of standardised content of behavioural interventions, delivery of interventions (psychologists or nurses or nurse counsellors) and the difficulty in identifying the effective components within these interventions, the committee agreed not to make a make recommendation for any specific behavioural intervention.

The committee discussed that though CPAP therapy is considered as the first line treatment of moderate and severe OSAHS and for symptomatic mild OSAHS if other management such as weight loss has not been effective (see discussion of evidence for CPAP in evidence reports E and F), the uptake and adherence can be low which limits its clinical effectiveness in patients with OSAHS. The committee from their experience stated that adhering to regular use of CPAP treatment has multiple benefits including improving the quality of sleep, reducing sleepiness during waking hours, preventing vehicle accidents, improving blood pressure control and reducing the risk of cardiovascular events. Therefore, they agreed that educational/supportive interventions to improve adherence of CPAP should be offered to all patients at initiation of therapy and as required at follow-up.

Optimal adherence to CPAP therapy is conventionally considered to be 4 hours or more per night or use for an average of more than 4 hours per night for 70% or more nights. Early adherence studies focused on control of sleepiness but there is evidence that increased CPAP use of more than 5 hours a night in OSAHS benefits other aspects of health such as control of blood pressure and cardiovascular risk. However, it is recognised that people can gain some benefit from a shorter period of use and individual response is variable. People should be encouraged to maximise their CPAP use to achieve optimal control of their symptoms, underlying conditions, sleep quality and quality of life.

Although evidence was available only for moderate and severe OSAHS, the committee agreed that the recommendations would be applicable to all severities, including people with mild OSAHS.

The committee stated that the choice of these interventions should be tailored to match individual patient needs. The committee agreed it is more helpful to focus on the content of the intervention rather than the specific type of intervention.

The committee highlighted the importance of timing of the delivery of CPAP education and support; they agreed that the initial contact and information session is a critical component in CPAP uptake and adherence.

The committee agreed that the recommendations reflect best practice, but current provision varies across NHS settings. Therefore, the recommendations will involve a change of practice for some providers.

The committee also discussed the importance of staff being appropriately trained to offer these interventions. They discussed that a low ratio of patients to staff should be maintained to allow individualised input but agreed that staffing issues are outside the remit of this guideline.

There was no evidence available for improving adherence for oral devices and positional modifiers in OSAHS; however, the committee agreed that the educational/supportive interventions for improving adherence for CPAP could be generalised for oral devices and positional modifiers as well.

There was no evidence for improving adherence in people who have difficulty using CPAP. The committee hence made a research recommendation for people who continue to find CPAP difficult to use despite having received some education from trained sleep professionals, access to support in the early adaptation period and/or clinical review to optimise aspects such as machine pressure, mask fit and humidification (Appendix I).

OHS

The committee agreed that the interventions to improve use of CPAP/non-invasive ventilation could be offered in people with OHS as the evidence for OSAHS population could be extrapolated to this population. The committee noted that the recommendations reflect best practice but are currently implemented to varying degrees across NHS settings and will involve a change of practice for some providers.

COPD-OSAHS overlap syndrome

The committee agreed that the interventions to improve use of CPAP/non-invasive ventilation could be offered in people with COPD-OSAHS overlap syndrome as the evidence for OSAHS population could be extrapolated to this population. The committee noted that the recommendations reflect best practice but are currently implemented to varying degrees across NHS settings and will involve a change of practice for some providers.

1.6.2. Cost effectiveness and resource use

There were no economic evaluations identified for this review question.

There was clinically important benefit for educational, supportive, behavioural and a mixture of these strategies for improving device usage (hours per night). There was also some evidence of better blood pressure control. The evidence for improvement in quality of life was mixed but from their experience, the committee explained that quality of life gains associated with using CPAP and other interventions could only be achieved and sustained if the device was used regularly. Poor adherence could lead to interventions no longer being cost-effective. The committee therefore agreed that providing education and support was reasonable because they can improve adherence and contribute to the cost-effectiveness of the intervention.

The provision of education and support is current practice for people who are newly provided with CPAP. This has traditionally been provided in the form of sleep specialist (usually nurse or physiologist)-led outpatient appointments but is now most likely to be conducted remotely. People receive their first outpatient appointment for CPAP when collecting the device. During this appointment people requiring CPAP receive advice and are educated on how to use their new device e.g. cleaning, plus are fitted with an appropriate mask and taught how to ensure the mask is on properly to avoid leaks. They have reminders of the importance of using the device regularly. This appointment when initiating people with CPAP is deemed to be important by the committee because they explained early encouragement and successful adherence is an important factor on whether people will be compliant over a longer time horizon. The provision of information is then typically provided again during a follow-up sleep specialist outpatient appointment 1 month after initiation with CPAP and then per annum thereafter. It is important to note that provision of education and advice are incorporated into these appointments, but they are not exclusively for providing education and support. For example, during the same appointment sleep specialist would explore whether people with OSAHS have adequate control of their symptoms and whether further assistance is required to improve symptoms (e.g. changing mask types, increasing machine pressure) and download data on adherence from the CPAP machine.

The provision of education and support is consistent with the minimum level of care all people should expect as explained in the Patient experiences guideline (CG138). It was therefore agreed provision of education and support should also be extended to people receiving positional modifiers or oral devices for OSAHS and CPAP or non-invasive ventilation for (COPD-OSAHS overlap syndrome and OHS). As these recommendations are consistent with what occurs in current practice, a significant resource impact is not expected due to these recommendations.

The committee noted that providing intensive behavioural interventions as described in some of the clinical studies would be quite costly. Due to the lack of cost effectiveness evidence and a concern that behavioural interventions could be interpreted in different ways (which would increase variation in practice) the committee opted to not make a recommendation for this intervention. Finally, in those people who have difficulty with using the device, the committee decided to make a research recommendation to explore a range of strategies (including behavioural strategies) that could be utilised to improve adherence.

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Appendices

Appendix A. Review protocols

Table 6. Review protocol: adherence (PDF, 415K)

Table 7. Health economic review protocol (PDF, 196K)

Appendix B. Literature search strategies

Sleep Apnoea search strategy 1_adherence

This literature search strategy was used for the following review;

What support improves adherence to CPAP or other interventions?

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.⁶⁰

For more information, please see the Methods Report published as part of the accompanying documents for this guideline.

B.1. Clinical search literature search strategy (PDF, 303K)

B.2. Health Economics literature search strategy (PDF, 345K)

Appendix H. Excluded studies

H.1. Excluded clinical studies

Table 15. Studies excluded from the clinical review for CPAP (PDF, 149K)

Table 16. Studies excluded from the clinical review for oral devices and positional modifiers (PDF, 131K)

H.2. Excluded health economic studies

Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2003 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below:

None.

Appendix I. Research recommendations

I.1. Interventions to improve CPAP adherence (PDF, 130K)

Tables

Table 1PICO characteristics of review question

Population	People (16 and older) with OSAHS, OHS or COPD-OSAHS overlap syndrome. Population will be stratified by: population: OSAHS, OHS, COPD-OSAHS overlap syndrome severity: mild, moderate, severe (based on AHI/ODI) devices: positive airway pressure devices, position modifiers, oral devices types of interventions (educational, behavioural, supportive)
Interventions	Short term or sustained behavioural intervention aimed at encouraging uptake, acclimation, improvement or maintenance of adherence to long term OSAHS, OHS, COPD-OSAHS overlap syndrome treatment. Examples may include educational interventions supportive interventions interactive interactions group-based interventions mindfulness-based interventions cognitive interventions behavioural interventions motivational strategies combination of multiple interventions.
Comparisons	any of the above vs no intervention Background level of information and support at the study centre (that must also be provided to intervention group)
Outcomes	Critical generic or disease specific validated quality of life measures (continuous) mortality (dichotomous) proportion adherent >4hrs/night for CPAP/non-invasive ventilation (dichotomous) adherence in hours/night for CPAP and oral devices (continuous) self-reported adherence (continuous) Important mood or anxiety withdrawals treatment related withdrawals (dichotomous) sleepiness scores (continuous, e.g. Epworth) apnoea-Hypopnoea index or respiratory disturbance index (continuous) oxygen desaturation index (continuous) CO₂ control (continuous) minor adverse effects of treatment (rates or dichotomous) driving outcomes (continuous) neurocognitive outcomes (continuous) impact on co-existing conditions: HbA1c for diabetes (continuous) cardiovascular events for cardiovascular disease (dichotomous) systolic blood pressure for hypertension (continuous)
Study design	RCTs systematic review of RCTs parallel or crossover to be included

Table 2Summary of studies included in the evidence review for CPAP

Study

Intervention and comparison

Population

Outcomes

Comments

Askland 2020⁵

Systematic review

41 studies

Inclusion study designs: Randomised, parallel-controlled trials of any duration.

For inclusion in the review, intervention and control groups must have either 1) received the same make of CPAP machine and pressure delivery mode (i.e. fixed, auto-titrating, bi-level, etc.) or 2) receive CPAP machines in a randomly distributed manner, such that machine make remained independent of group assignment.

Intervention group

Any short-term or sustained behavioural intervention aimed at encouraging uptake, acclimation, improvement or maintenance of CPAP adherence among people with a diagnosis of OSA. Examples of modalities that may fall under ‘behavioural interventions’ include educational, supportive, interactive, group-based, mindfulness-based, cognitive, behavioural, motivational or approaches utilising a combination of these strategies.

Control group

Participants in the control group may receive instruction that would be used by the study centre in question, provided that the equivalent ‘background’ level of instruction was also offered and/or delivered to the intervention group.

Participants were adults of either sex with a diagnosis of obstructive sleep apnoea (OSA) diagnosed using a recognised sleep diagnostic tool giving an Oxygen Desaturation Index (ODI) of ≥5 per hours or an Apnoea Hypopnea Index (AHI) ≥5 per hour. Trials that explicitly recruited patients with central sleep apnoea were not eligible for inclusion.

Primary outcomes

CPAP machine usage (hours/night) as measured by:

microprocessor and monitor that measure pressure at the mask for every minute of each 24-hour day
counter output that records the cumulative time that power is turned on for a CPAP machine (this does not provide information on actual time of day and duration of CPAP used during each 24-hour period)
subjective participant reports of the duration of CPAP use

Secondary outcomes

proportion of participants adherent (≥4 hours/night)
symptom scores such as the Epworth Sleepiness Scale (ESS);
disease-specific quality of life scores such as Functional Outcomes of Sleep Questionnaire (FOSQ) or Calgary Sleep apnoea Quality of Life Index (SAQLI) scores; and
Withdrawals from the study.
oxygen desaturation index (ODI), apnoea hypopnoea index (AHI)

We have used the data analysed by the Cochrane review team in this review.

Majority of the studies for each comparison was in people with severe OSAHS (based on mean AHI) hence they have been categorised as severe OSAHS. When moderate OSAHS studies were included in this stratum, we have downgraded the evidence for indirectness.

Aloia 2001⁴

RCT

Country: USA

Participants were randomised into experimental intervention (n=6) or control (n=6).

Intervention: After their CPAP–PSG night, subjects returned to the clinic for a follow-up with the sleep medicine physician. All subjects were then administered the first of two one-to-one sessions. The second session was scheduled after subjects had used CPAP for one full week (typically 1 week after the first session). Each session for both the experimental and control groups lasted approximately 45 minutes and was conducted by a clinical psychologist. Subjects in the experimental condition were administered an intervention designed to educate them on their individual OSAHS severity and the efficacy of CPAP based on PSG. The specific content of the two experimental sessions were:

SESSION 1

Review subject’s sleep data

Review symptoms noticeable to the subject (e.g., anergia, EDS)

Review symptoms not apparent (e.g., hypertension, cardiac problems)

Review results of performance on cognitive tests

Rate the importance of treatment

Review PSG with CPAP and specify how this might address the above problems

Discuss the advantages and disadvantages of treatment

Develop goals for therapy

SESSION 2

Examine compliance data for the first week

Discuss noticeable changes with treatment

Discuss changes not apparent (e.g., hypertension, cardiac problems)

Troubleshoot discomfort

Discuss realistic expectations of treatment

Review treatment goals

Control: Two sessions: general discussion of sleep architecture and opinions on sleep clinic

Study duration: 12 weeks

N = 12 existing patients at investigator sleep centre with OSA.

Participants had received prior treatment with CPAP

Inclusion criteria: > 55 years of age, RDI (AHI): > 10, Mini Mental Status Examination: > 25

Exclusion criteria: other ICSD, other treatment for apnoea, claustrophobia

Baseline Characteristics: Mean age: 63.4, AHI: 43.5, Desaturation: 77.05 ± 9.47.

Baseline characteristics not reported: gender, BMI, ESS.

Machine usage (hours/night) at 1 week, 4 weeks, 3 months.
N of adherent participants (>= 6 hours per night of usage)

Included in Cochrane review Behavioural vs control

Severe OSAHS based on mean AHI

Aloia 2013³

RCT

Country: USA

Participants were randomised in a 1:1:1 ratio into one of three groups -- standard care (SC, n=74), education (ED, n=80) and motivational enhancement therapy (MET, n=73)--balancing for age, sex, education, apnoea severity, and Epworth Sleepiness Scale score.

People in the MET and ED groups each received two, 45-min, face-to-face individual counselling sessions by a trained nurse 1 week (7 ± 2 days) and 2 weeks (14 ± 2 days) after initiating PAP treatment. Intervention sessions were delivered after 1 week of PAP use. One additional booster phone call was made to each participant in the MET and ED groups at week 3 of PAP use.

MET: motivational enhancement therapy (MET) MET intervention focused on helping patients resolve their ambivalence regarding consistent use of PAP. The nurse counsellor strived to maintain an atmosphere of collaboration and partnership, rather than education. The counselling sessions were tailored to the individual’s readiness to change; less directive approaches were used for those who were ambivalent about using PAP (e.g., asking permission from the patient to discuss aspects of their life that were important to them and how they might be related to sleep), whereas direct problem solving was used for those who were more ready to use and maintain use of the device.

Key components of the intervention included:

(1): assessing readiness and confidence to change, each on a scale of 1 to 10, and exploring the reasons for choosing that value;
(2): discussing what the patient already knows about the effects of sleep apnoea and PAP on health, eliciting permission to provide feedback about such health effects, providing the information, and eliciting the patient’s interpretation of the information (“elicit-provide-elicit” process);
(3): perceived benefits of PAP in order to enhance outcome expectations;
(4): goal setting, consistent with both MI style and with social cognitive theory (setting specific, attainable, and realistic goals for use, if motivated);
(5): identification of rewards for hard work on adherence to PAP; and
(6): discussion of important values and goals and the ways in which PAP adherence facilitates and hinders these goals.

ED: Education regarding pathophysiology of apnoea, its medical and behavioural consequences, and the benefits of treatment; presented in standardized formats, with no tailoring to participant readiness.

SC: Provided to all participants, consisted of standard clinical care delivered by the authors’ sleep disorders centre.

Study Duration: 12 months

N= 227 with OSA.

Inclusion Criteria: Age 25-85 years, moderate to severe OSA (AHI > 15) by full in-laboratory overnight polysomnography, naïve to PAP therapy.

Exclusion criteria: Diagnosis by split-night PSG; evidence of severe neurological condition or unstable psychiatric illness; sleep disorder other than OSA (including primary central sleep apnoea), CHF, ESRD.

Baseline Characteristics: 34% female. Mean age 50.2 (±11.1). Mean AHI 46.7. Mean ESS 12.1. Mean BMI 35.3 kg/m².

CPAP usage (hours/night) at 1, 2, 3, 6, 12 months.
Withdrawals

Adherence was measured nightly during the course of the year-long study. Participant average adherence from the beginning of the experiment up to 1, 2, 3, 6 and 12 months were used in analyses, i.e., cumulative mean responses were used).

Decisional balance measure consists of both pro items, which assess the benefits of engaging in a particular behaviour, and con items, which assess the costs to the patient of engaging in PAP adherence. A five-point Likert scale was used to rate each item, with 1 being “not important at all” and 5 being “extremely important.” The self-efficacy scale was constructed using assess the extent to which patients believed that they could do the required tasks.

Decisional balance and self-efficacy measurements were taken concurrent with the 3-, 6-, and 12-mo PAP adherence measurements

Trialists included two intervention arms, one educational and one behavioural. MET vs. Control included in Behavioural meta-analysis. ED vs. control included in Educational meta-analysis.

Included in Cochrane review

Behavioural vs control

Severe OSAHS based on mean AHI

Bakker 2016⁸

Open-label, parallel-arm, RCT

Country: USA

Eligible participants entered a run-in phase before randomisation, consisting of 14 days wearing a nasal CPAP mask during sleep (without a CPAP device). Participants who reported using the mask during the majority of the run-in and who were willing to continue using the mask were eligible for randomization. Randomization took place in a 1:1:1:1 ratio with a block size of 4, based on three stratification factors: diagnostic study (full night or split night with titration), site, CVD status (established or risk factors) to one of four study arms (two control conditions, two treatment conditions): conservative medical therapy (n=44), sham CPAP (n=42), active CPAP (n=42), or active CPAP +ME (n=41). Analyses in the Bakker et al, 2016 report compared the active CPAP and CPAP + ME arms only.

Intervention (Active CPAP + ME): Motivational enhancement (ME):

ME is a behavioural intervention devised on the principles of motivational interviewing. The premise of the therapy is to honour the natural ambivalence that accompanies any change to behaviour and to approach the patient in a thoughtful and empathetic manner that elicits critical thought to maximize behaviour change.

The overall goal of each ME session was to resolve the subjects’ ambivalence toward establishing consistent CPAP usage patterns and increase the subjects’ confidence toward using CPAP regularly. The psychologist delivering the intervention aimed to maintain a collaborative—rather than educational—style of interaction with each subject. Each session involved a discussion regarding the subject’s readiness to begin CPAP, the subject’s understanding of the health risks associated with untreated OSA, and the extent to which the subject believed that consistent CPAP use could resolve these risks.

Each subject was encouraged to set concrete goals regarding their future CPAP use and identify rewards that they would provide themselves when those goals were achieved.

ME was delivered during 1-hour in-person sessions at baseline and week 1, which included an educational video, and during phone calls of 10 to 30 minutes with the same psychologist at weeks 3, 4, 8, 12, 20, and 32. In-person sessions were audio recorded, to allow independent assessment of fidelity to the intervention framework.

Control (Active CPAP): For the Bakker et al, 2016 report and the present Review, CPAP only arm served as the control.

Study Duration: 12 months.

N=83 participants with OSA

Inclusion criteria: AHI 4%, ≥ 10 or AHI 3%, ≥ 15; 45 to 75 years with established CVD or cardio metabolic disease (established coronary artery disease (≥ 70% stenosis in at least one major coronary artery), prior myocardial infarction, coronary artery revascularization procedure, ischemic stroke, or diabetes) OR 55 to 75 years with at least three CVD risk factors (male sex, BMI of 30 kg/m² or more, hypertension, dyslipidaemia, and ≥ 10 pack-years of smoking).

Exclusion criteria: cardiovascular event < 4 months before enrolment, prior CPAP, ESS > 14 of 24, drowsy driving within 2 years, commercial driving, or an uncontrolled medical condition (including central sleep apnoea, heart failure, uncontrolled hypertension, severe hypoxemia, anaemia, and renal insufficiency).

Baseline Characteristics: 33% female. Mean age 63.8 (NR). Mean AHI 22.8. Mean ESS NR. Mean BMI 31.1 kg/m².

CPAP usage (hours/night) at 6, 12 months

Included in Cochrane review

Moderate OSAHS based on mean AHI

Berry 2020¹²

Randomised parallel-group trial.

Country: USA

(n=124) Intervention 1: Cloud-based sleep coach (CBSC)

Participants randomised to SC+CBSC follow-up received all elements of standard care and, in addition, interaction/communication from the CBSC service. The participants were informed that they would receive a telephone call from the CBSC system in 3 to 4 days to discuss their experience with therapy. Further contact from the CBSC could be expected if their adherence goals were not reached. All participants received calls on day 3 to 4 and on day 32 after PAP initiation. The participants were also provided with information on, and encouraged to use, the mobile application (PAPapp), allowing them to view their current adherence.

(n=126) Intervention 2: standard care

Participants attending PAP setup classes were educated about use of their PAP device, including cleaning, ramp option, and humidification. All patients were encouraged to use therapy nightly for as long as they can, preferably for the entire time they sleep. Each participant was fitted with a mask based on physician order, participant preference, and the ability to obtain a good mask seal. The type of PAP device (auto-adjusting CPAP or auto-adjusting bilevel PAP) and pressure settings were determined by physician order. Participants practiced putting on their masks and turning on the PAP device. All devices contained wireless modems with information accessed via a cloud-based programme. Device data were uploaded into the database via wireless modems programmed to call in automatically. Device data were associated with the individual participant based upon the serial number of the device and modem entered by the staff. All PAP devices had the ability to deliver heated humidification. At the PAP setup class, participants received information about the PAPapp (written information also supplied with each PAP unit).

Participants were provided with telephone numbers for PAP supply replacement and for PAP treatment issues. They were also encouraged to use the secure messaging service “My Healthy Vet” to facilitate communication with the sleep providers. Participants had a 6-week inspection of adherence and efficacy data if ordered by the physician reading the sleep study. Pressure settings could be changed remotely based on physician order. A participant could be scheduled for an individual mask fitting CPAP RT appointment if discomfort or leak issues were significant. A 3-month (90 to 120 days) sleep clinic visit with a sleep provider (physician or physician extender) was scheduled.

(n=250) (Standard care, n= 126, standard care + cloud-based sleep coaches (CBSC), n= 124).

Inclusion criteria: Age 21 to 75 years (men and women)

Diagnostic apnoea-hypopnea index ≥ 15 events/h (diagnostic polysomnography [PSG], diagnostic portion of split PSG, or home sleep apnoea test)

Eligible for treatment with automatically adjusting continuous positive airway pressure or bilevel positive airway pressure

Residence in area covered by wireless network.

Age: CBSC 54.9 ± 11.5 years; control: 55.2 ± 13.4 years

AHI: CBSC 36.6 ± 20.6 events/h; control 36.7 ± 21.1 events/h

Gender male %: CBSC 88.7%; control 89.7%

Sleepiness: ESS: CBSC 11.2 ± 6.0; control 10.8 ± 6.1

AHI
ESS
Number of days used >4 hours at 3 months

Follow-up 3 months

Severe OSAHS based on mean AHI

Bartlett 2013⁹

Randomised parallel-group trial.

Country: Australia

Prior to recruitment, a randomization sequence by group using random permuted blocks with a 1:1 allocation ratio to control arm, Social Interaction (SI, n=97) or intervention arm, Social Cognitive Therapy (SCT, n=109).

SCT: Intervention was based on social cognitive theory factors, including perceived self-efficacy, outcome expectations, and social support. Participants were encouraged to list goals, given slide presentations to discourage unhelpful thoughts of CPAP side effects, taught relaxation strategies, and given additional booklets containing information about sleep OSA/CPAP, and general health.

SI: a basic social intervention was given to ensure that equal time was spent with all study participants; SI group was shown a 15-minute video that followed a patient’s journey from their baseline diagnostic sleep study to being diagnosed with OSA and undergoing a CPAP titration study.

Study Duration: 6 months

N=206 participants with moderate-severe OSA referred to CPAP therapy.

Inclusion criteria: None reported other than moderate-severe OSA.

Exclusion criteria: Unable to understand fluent English, any previous use of CPAP.

Baseline Characteristics: 32% female. Mean age 48.1 (±13.2). Mean AHI 34.9. Mean ESS 11.9. Mean BMI 30.4 kg/m².

CPAP usage (hours/night) at 6 months.
N of adherent participants (usage ≥ 4 h per night)
Sleepiness (ESS)
QoL (FOSQ)

CPAP usage was assessed at 7 nights, then 1, 3, and 6 months.

Included in Cochrane review

Severe OSAHS based on mean AHI

Basoglu 2011¹⁰

Randomised, parallel-group study

Country: Turkey

Participants were randomised into video education intervention (n=66) or control (n=67).

Intervention: 10-Minute videotape on OSA, its consequences and CPAP therapy. In addition, routine information on diagnosis and treatment of OSA given by physician

Control: Standard information on OSA and CPAP therapy given by the same physician

Study duration: 24 weeks

N = 133 newly diagnosed moderate-to-severe OSAS patients

Inclusion criteria: newly diagnosed, moderate to severe OSA, CPAP naive

Exclusion criteria: use of sedatives, drug abuse, cardiac co-morbidities, COPD, other sleep disorders

Baseline Characteristics, by group:

Intervention group: Age: 53.7, Male sex: 82%, AHI 61, ESS: 10.3, BMI: 33.2.

Control group: Age: 54.4, Male sex: 70%, AHI: 57.4, ESS: 12.4, BMI: 33 kg/m²

Number of adherent participants (CPAP use for at least four hours/night for at least 70% of nights at 1, 3, 6 months
Sleepiness (ESS)

Included in Cochrane review

Unpublished information on study design and outcomes obtained from study authors

Severe OSAHS based on mean AHI

Bouloukaki 2014¹³

Randomised, parallel-group study.

Country: Greece

Eligible patients (n=3100) were randomly assigned in a 1:1 ratio to receive either the standard intervention (n=1550), of usual follow-up care, or the intensive intervention (n=1550), with augmented follow-up care based on additional appointments at the CPAP clinic, telephone calls and education.

Intensive Intervention: Patients received the same features as standard group, with the addition of follow-up visits involving patients’ partners or family. All patients attended a 15-minute video education session cover OSAHS related topics, including the syndrome itself, treatment options, and the benefits of adherence to therapy. This was followed by a 10-15-minute lecture used to reinforce key concepts. During the first week of CPAP set-up, patients were contacted by the nurse, on the second and seventh day, via telephone in order to discuss any concerns they might have regarding air pressure, mask fitting, leaks and other issues as they arose. During the first month of treatment, patients were instructed to keep a sleep diary, and were reviewed by a sleep specialist on the 15^th and 30^th day of treatment.

Standard Care: patients were reviewed in the outpatient sleep clinic at 1 month, at 3-month intervals during the first years, and every 6 months afterwards. During these appointments, a clinical assessment was made, and patients were further encouraged to use the device. If there were doubts about compliance, the referring physician made personal contact with the patient in order to resolve barriers to adequate compliance.

Study Duration: 2 years

N=3100 patients with newly diagnosed sleep apnoea randomised to either the standard group (usual follow-up care) or the intensive group (additional visits, telephone calls, and education).

Inclusion criteria: newly diagnosed with OSAHS by PSG, moderate-to-severe OSAHS, no history of previous CPAP therapy, and above-elementary school education.

Exclusion criteria: refusal to participate, refusal of CPAP therapy, central sleep apnoea syndromes, obesity hypoventilation syndrome, restrictive pulmonary and restrictive chest wall diseases, severe congestive heart failure, a history of life-threatening arrhythmias, severe cardiomyopathy, long-term oxygen therapy, family or personal history of mental illness, drug or alcohol abuse, severe cognitive impairment, concurrent oncological diseases, and a history of narcolepsy or restless legs syndrome.

Baseline Characteristics: 25% female. Mean age 55.6 (±10.2). Mean AHI 52. Mean ESS 12.1. Mean BMI 37.8 kg/m².

CPAP usage (hours/night) at 1 month, 2 years
Number of adherent participants (>= 4 hours/night for >= 70% of nights)
Sleepiness (ESS)
QoL (SF-36)
Withdrawals

Included in Cochrane review

Severe OSAHS based on mean AHI

Chen 2015¹⁶

Randomised, parallel-group study.

Country: China

85 participants were randomised to nurse-led intensive vs standard support, of which 5 refused to participate (group allocation of refusals not reported), resulting in n=40 receiving intervention and n=40 receiving control condition.

Intervention: Hospital health education, consisting of pre-treatment 30-minute educational video that explained the pathogen, mechanism, risks, benefit, and treatment methods for SAHS; personalized guidance from a nurse; and a SASH Health education Manual. In addition, several patient self-management interventions were delivered including: 15-minute interview with nurse for troubleshooting within 5 days of receiving CPAP treatment, nurse home visits after CPAP treatment was initiated, healthy lifestyle (diet, exercise) guidance, and a psychological intervention, informing patients of the importance of maintaining a good mental state for disease rehabilitation, and teaching the patients methods and techniques on how to respond to anxiety and depression. Finally, each subject in the intervention arm received a ~30-minute consultation with sleep physician within 1 month of CPAP initiation.

Control: ~30-minute consultation with sleep physician at 1, 3, 6 and 12 months.

Study Duration: 12 months.

N=85 participants with new SAHS diagnosis.

Inclusion criteria: AHI >15, daytime sleepiness, two major symptoms of the syndrome, lived within 100 miles from Zhejiang.

Exclusion criteria: previously received CPAP therapy, suffering with chronic obstructive pulmonary disease, asthma, or neurological problems.

Baseline Characteristics: 38.3% female. Mean age 50.4 (NR). Mean AHI 54.5. Mean ESS 13. Mean BMI 32.5 kg/m².

CPAP usage (hours/night) at 1, 3, 6, 12 months.
Sleepiness (ESS)
QoL (SF-36)

Included in Cochrane review

Severe OSAHS based on mean AHI

Chervin 1997¹⁷

Randomised parallel-group trial

Country: USA

No information provided as to the group allocation of all randomised subjects. Allocation Ns only available for the 33 participants who completed the study: Intervention group 1 (n=12), Intervention group 2 (n=14), control (n=7).

Intervention 1: Telephone call each week during trial (max trial time of two months)

Intervention 2: Two printed documents

Control: No additional support

Study duration: 8 weeks

N = 40 subjects with OSA (about to start or already receiving CPAP) recruited from clinic.

Baseline Characteristics: Mean age 51.7. Mean AHI 49.4. ESS 10.9 ± 5.1. Lowest 02 Sat 75.6% (± 14.4). MSLT 6 (± 3.9)

Machine usage (hours/night) at 1 to 2 months
Dropouts/Lost-to-follow-up

Included in Cochrane review

Two of 33 used Bi-PAP. Both CPAP-naive users and those who had been on CPAP before trial were studied. Reading done at enrolment and at between 1 to 2 months after enrolment

Difference in AHI between active and control groups at baseline.

Trialists included two intervention arms, one educational and one supportive. Intervention 1 (telephone support) vs. Control included in Supportive meta-analysis. Intervention 2 (educational documents) vs. control included in Educational meta-analysis.

Severe OSAHS based on mean AHI

Dantas 2015²⁰

Randomised parallel-group trial.

Country: Portugal

Motivational interviewing: a single group session is delivered 1 month after beginning APAP therapy to promote adherence among patients newly diagnosed with OSAS. This standardised group educative session was conducted by a pulmonologist, a psychologist, and a respiratory physiotherapist and includes information about OSAS and APAP treatment goals and function mode.

Two questions were used to gauge the patient’s conviction and confidence:

“How important to you is the use of the device in your treatment?” and

“How confident are you that you can use the device?”

The degree of conviction and confidence permitted to establish the stage of change in each patient and to define specific strategies to be applied in an individual 10-min-long interview. During the intervention, the patient’s beliefs, expectations, and feelings were assessed. The authors postulated that according to Prochaska and co-workers that a pre-contemplation stage corresponded to a score of 0 to 3 in the conviction and confidence scales. At this stage, patients were informed about the disease, the possible benefits of the treatment, and the risks of noncompliance with the treatment. To be considered in the contemplation stage, patients had to rate their conviction between 2 and 5 and their confidence between 5 and 8. At this stage, the intervention focused on emphasizing intrinsic motivation and reaffirming the patient’s autonomy regarding whether or not to adhere to the treatment. When patients rated their conviction between 6 and 8 and their confidence between 7 and 10, they were considered in the preparation stage. In this stage, they were assisted with developing concrete plans and clarifying objectives. At the end of the intervention, a new interview was scheduled, and written information was delivered about OSAS disease and treatment. control: Participants received only standardized information about APAP (the device and interface) during the 10-min interview, regardless of their confidence and conviction scores.

“Control Group 2” (CG2) is a convenience sample submitted to standard procedures, which was not part of the randomization procedures. CG2 is excluded from Review.

Study Duration: 2 months

N=41 patients diagnosed with OSAS, meeting the criteria for APAP therapy, were randomly allocated to one of two groups:

Intervention Group (IG) brief educational intervention (n=20) using motivational strategies or control group 1 (CG1, n=21). (‘Control Group 2’ (CG2) comprised a convenience sample selected from the sleep lab’s initial consultations but were not part of the randomization procedures.).

Inclusion criteria: >18 years old, AHI >= 15, diagnosis that indicates ventilator (CPAP) therapy, willingness to participate in the study.

Exclusion criteria: chronic obstructive pulmonary disease, neuromuscular disease, heart disease, neurological disease, and patients taking psychotropic drugs.

Baseline Characteristics: 23% female. Mean age 56.5 (±10). Mean AHI NR. Mean ESS 9.9. Mean BMI 32.9 kg/m².

CPAP Usage (hours/night) at 1 and 2 months.
% Days of APAP use (>4 h per night on 70 % of the nights during a period of 30 consecutive days)
Sleepiness (ESS)
AHI

Moderate and severe OSAHS

DeMolles 2004²⁴

Randomised parallel-group study. Methods of randomisation not reported

Country: USA

Participants were randomised to Telephone-linked communications technology (TLC, n=15) versus usual care (UC, n=15).

UC: Described as usual medical care, patient education and demonstration of equipment use.

TLC: UC plus computerised digitised human speech programme. TLC asks questions designed to elicit information from participant regarding adherence, education and reinforcement.

Study duration: 8 weeks

N = 30 patients being started on CPAP for OSAS.

Inclusion criteria: Starting nasal CPAP therapy; > 18 years; English-speaking; AHI > 15

Exclusion criteria: Prior CPAP use.

Baseline Characteristics: Mean age 46. Mean BMI 38 kg/m². Mean AHI 40.

Functional Outcomes of Sleep Questionnaire: TLC: 15.3, Control: 13.8

CPAP usage (hours/night) at 2 months
QoL (FOSQ)

Included in Cochrane review

Severe OSAHS based on mean AHI

Diaferia 2017²⁶

Randomised parallel-group study.

Country: Brazil

Participants were randomised to 2 of 4 study groups were considered: CPAP only (n=27) or CPAP + myofunctional therapy (MT, n=22).

[Full study had 2 additional arms: placebo myofunctional therapy (n=24) and myofunctional therapy (n=27) in addition to those noted above for this review.]

*CPAP only: standard care, including attending a PSG to determine optimal pressure of CPAP

Myofunctional therapy +CPAP: Myofunctional therapy consisted of muscular endurance exercises aimed at toning the oropharynx muscle groups; optimizing muscle tension mobility; and adjusting the position of the soft tissues and the suitability of the chewing, sucking, swallowing, and breathing orofacial functions, according to previously standardised protocols.

The therapies were performed at home for 3 months with three daily exercise sessions of 20 min each.

Study Duration: Patients underwent evaluations before and after 3 months of treatment, and after 3 weeks wash-out period.

For this Review, only the N=49 (male) participants with OSAS

Inclusion criteria: Men aged 25-65 years, BMI of less than 35 kg/m², confirmed OSAS diagnosis (via polysomnographic criteria).

Exclusion criteria: Female gender (excluded “since hormonal decline in the menopausal phase could lead to loss of muscle mass, causing a bias in the study”), other sleep disorders, previous treatment for OSAS, serious or decompensated clinical or psychiatric medical illnesses, such as congestive heart failure, cardiomyopathy, chronic obstructive pulmonary disease, chronic active hepatitis, liver cirrhosis with severe symptoms, myasthenia gravis, demyelinating disease, motor neuron disease, depression, schizophrenia, obsessive compulsive disorder, disorder anxiety, bipolar disorder, eating disorder, attention deficit disorder, and hyperactivity; patients who used alcohol, stimulants or sedatives; and patients with grade III or IV palatine tonsils, grade II or III septal deviation, or evident micrognathia.

Baseline Characteristics: 0% female. Mean age 46.9 (±9.9). Mean AHI NR. Mean ESS 12. Mean BMI 28.3 kg/m².

CPAP usage (hours/night) at 1 week, 1 and 3 months
N of adherent participants (usage ≥ 4 h per night on 70% of nights)
Sleepiness (ESS)

Included in Cochrane review

Only CPAP and CPAP + Myofunctional therapy groups included in Review/meta-analysis.

Falcone 2014²⁹

Randomised, parallel-group study.

Country: Italy

Participants were randomised into educational support (ES, n=103) or standard support group (SS, n=103).

SS: Sleep medicine physician provided each subject a full explanation (~10 minutes) of the need for and benefits of CPAP. Prior to CPAP titration the subjects received education regarding CPAP operation, mask placement, and a 20-min period of auto-CPAP exposure.

ES: In addition to standard support, each educational support group subject viewed 2 consecutive PSGs on the computer screen: the first recorded during a standard diagnostic overnight polysomnography, and the second during a full-night polysomnography with nasal CPAP. The subject’s attention was drawn only to the flow and oxyhaemoglobin saturation curves.

Study Duration: 12 months

N=206 newly diagnosed patients with OSA

Inclusion criteria: newly diagnosed OSA, AHI ≥15 events/h, with or without daytime symptoms.

Exclusion criteria: COPD, any global respiratory failure, central sleep apnoea syndrome, previous diagnosis of congestive heart failure or cardiomyopathy, any chronic neurological disorder, any severe mental or psychological impairment.

Baseline Characteristics: 25% female. Mean age 61.3. Mean AHI 54. Mean ESS 11.2. Mean BMI 32.1 kg/m².

CPAP usage (hours/night) at 1, 3, 12 months.
Sleepiness (ESS)

Included in Cochrane review

Severe OSAHS based on mean AHI

Fox 2012³⁰

Randomised parallel-group study

Country: Canada

Participants were randomised to telemedicine intervention (TM, n=39) or standard care (SC, n=36).

TM: Physiological data (PAP adherence, applied PAP, mask leak, residual respiratory events) were downloaded using modem attached to the PAP device and sent across the telephone line each morning. Downloaded information was reviewed every weekday except holidays by the research coordinator, who contacted the participant if poor compliance or other problems with treatment (e.g. mask leak) were detected. Participants were advised over the phone or visited the PAP coordinator. Standard care identical to control group

SC: 20-Minute orientation to PAP session and mask fitting. Participants contacted after two days to check adherence and to troubleshoot problems, followed up at four to six weeks and at three months; each time, physiological data downloaded from machines and any problems with treatment addressed. In addition, data downloaded at eight weeks

Study duration: 12 weeks

N = 75 adults with moderate-severe OSA by PSG.

Inclusion criteria: adult (≥ 19 years), moderate to severe OSA (AHI ≥ 15)

Exclusion criteria: active cardiopulmonary or psychiatric disease, previously treated for OSA, no access to telephone line in bedroom, not able to return for follow-up

Baseline Characteristics: 20.1% female. Mean age 53.5 (±11.2). Mean AHI 41.6. ESS 9.8. BMI 32.4 kg/m².

Machine usage (minutes per day)
Adherence on nights PAP used
% days PAP used
Decrease in ESS
AHI on treatment

Included in Cochrane review

Severe OSAHS based on mean AHI

Hanger, 2018³⁴

Randomised, parallel-group study.

Country: USA

(n=23) Intervention 1:

Telemedicine care group (TM).

In addition to standard care, participants randomised to the TM group received the intervention, which entailed an initial call to all participants after one week of PAP therapy. CPAP usage data was monitored weekly via a web-based database. Use of CPAP of less than 4 hours per night, on less than 70% of nights (or more than 2 days), in the preceding week of monitoring, was considered non-adherent and triggered a phone call from the research coordinator to provide support and troubleshooting as needed. Participants were seen back in clinic after 6 weeks, per standard care. Data monitoring, as outlined above, continued for the first 3 months of CPAP usage. The study period culminated with a phone call, by the author, to all participants from both study arms, at the end of 3 months, to discuss any questions or concerns and to survey satisfaction of their follow-up care.

(n=23) Intervention 2: Standard care

Participants in the standard care (SC) group received the standard follow-up regimen currently used by the Sleep Center. Following diagnosis of moderate or severe OSA and the participant was prescribed CPAP therapy. Patients obtained equipment; they were fitted with a mask and given instructions on set up, use and care of the PAP machine. Devices were equipped with wireless data transmission technology. Patients were advised to call for any equipment concerns and the Sleep Center with any other concerns or questions related to PAP use; they were seen back in clinic after 6 weeks to discuss adherence and efficacy, review device data, and to address any issues or questions they may have. If patients were doing well, they were seen back yearly for monitoring, with more frequent follow-up if needed.

(n=56) (standard care, n=23); telemedicine (n=33).

Inclusion criteria: Adults, at least 18 years of age, newly diagnosed with moderate to severe OSA on HSAT or PSG; provision of CPAP device by DME with wireless data transmission capability and English speaking.

Age (mean SD): medicine 60.0±14.2; control: 51.4±13.8

AHI: telemedicine38.0±21.1; control 37.27±18.8

Gender: female%: telemedicine 42; control 42.1

Sleepiness: ESS: telemedicine 8.8±4.9; control 11.3±5.5

AHI at 3 months
ESS at 3 months
Number of days used >4 hours at 3 months

Severe OSAHS based on mean AHI.

Hoet 2017³⁶

Randomised, parallel-group study.

Country: Belgium

Participants were randomised to usual care (UC, n=23) or telemonitoring (TM, n=23) group.

TM: In addition to usual care, telemonitoring device was attached to CPAP machines. Via this device, sleep laboratory technical staff analysed participant data and contacted patients in the case of air leaks, residual AHI >10/h, or CPAP use less than 3 hours in three consecutive days

UC: Group educational session 1 month after CPAP initiation, and a visit to the pneumologist scheduled and 1.5 and 3 months after CPAP initiation.

Study Duration: 3 months

N=46 patients with a recent diagnosis of moderate to severe OSAS

Inclusion Criteria: At least 18 years old, recently diagnosed with OSAS (AHI ≥20/h).

Exclusion criteria: previous exposure to CPAP therapy, mixed/predominantly central sleep apnoea, language barriers, cognitive or psychiatric disorders making it difficult to comprehend information regarding CPAP therapy and provide informed consent, significant comorbidities such as severe chronic obstructive pulmonary disease or hypoventilation syndromes.

Baseline Characteristics: 63% female. Mean age 56.6 (±13.5). Mean AHI 49.5. Mean ESS 11. Mean BMI 31.5 kg/m².

CPAP usage (hours/night) at 3 months.

Included in Cochrane review

Severe OSAHS based on mean AHI

Hoy 1999³⁷

Randomised, parallel study. Method of randomisation not reported. ITT

Country: UK (Scotland)

Participants were randomised into usual care (UC, n=40) or Telemonitoring (TM, n=40).

TM: Full explanation of need for and benefits of CPAP by sleep physician, 20-minute video education programme, given mask to try for 20 minutes, titration of CPAP pressure overnight with following day discharge, nurses telephoned on days two and 21, reviewed in hospital at one, three and six months. Initial education at home with partner, two extra nights in hospital, sleep nurses’ home visits to participant and partner at seven, 14 and 28 days and four months after starting CPAP

UC Full explanation of need for and benefits of CPAP by sleep physician, 20-minute video education programme, given mask to try for 20 minutes, titration of CPAP pressure overnight with following day discharge, nurses telephoned on days two and 21, reviewed in hospital at one, three and six months

Study Duration: 6 months

N = 80 patients with SAHS.

Inclusion criteria: AHI ≥ 15, plus daytime sleepiness or two other major symptoms of the syndrome; resident within 50 miles of Edinburgh

Exclusion criteria: prior use of CPAP; coexisting COPD, asthma or neurological problems

Baseline Characteristics: 2.5% female. Mean age 51 (±11). Mean AHI 58. Mean ESS 13. Mean BMI 33 kg/m².

Machine usage (hours/night) at 6, 12 months
Quality of life
Symptom score (in-house questionnaire)
Epworth Sleepiness Scale score

Included in Cochrane review

Severe OSAHS based on mean AHI

Hui 2000³⁸

Randomised, parallel-group study

Country: China (Hong Kong)

Participants were randomised to basic CPAP support (BS, n=54) or augmented support (AS, n=54)

AS: 10-Minute CPAP education programme by respiratory nurse, brochure on OSA and CPAP treatment in Chinese, short trial CPAP therapy with comfortable mask for 30 minutes, CPAP titration on second night of study by AutoSet, nursing support following day, follow-up by nursing staff and physician at 1 and 3 months. Locally produced 15-minute videotape, additional nurse led 15-minute educational session, review by physicians at weeks one and two, respiratory nurse telephone call on days one and two, weeks one, two, four, eight and 12

BS: 10-Minute CPAP education programme by respiratory nurse, brochure on OSA and CPAP treatment in Chinese, short trial CPAP therapy with comfortable mask for 30 minutes, CPAP titration on second night of study by AutoSet, nursing support following day, follow-up by nursing staff and physician at 1 and 3 months.

Study duration: 12 weeks

N = 108 patients with newly-diagnosed OSA.

Inclusion criteria: diagnosis of OSA (AHI > 10 and subjective daytime sleepiness)

Exclusion criteria: none reported.

Baseline Characteristics: 10% female. Mean age 45 (±11). Mean AHI 48. Mean ESS 12.8. Mean BMI 30 kg/m².

Machine usage (objective and participant reported)
At least four hours of CPAP use/night for at least 70% of nights/week)
Quality of life
ESS
SAQLI

Included in Cochrane review

Severe OSAHS based on mean AHI

Hwang 2017³⁹

Cluster-randomised parallel-group study

Country: USA

Classes (and all participants in each class) were randomised (1:1:1:1) to one of four arms: 1) web-based OSA education (Tel-Ed, n=380), 2) telemonitoring and automated feedback (Tel-TM, n=375), 3) Tel-Ed + Tel-TM (Tel-Both, n=346), and 4) usual care (UC, n=354) using a four-arm, randomised, factorial design.

Usual Care: All patients attended a 1-hour, small-group education class with HSAT setup. After the trial, those willing to continue CPAP were prescribed therapy and scheduled for a 3-month follow-up appointment.

Tel-Ed: Education about the pathophysiology of OSA, health-related risks, impact on daytime vigilance, introduction to CPAP therapy. For patients eventually determined to have OSA, a link to a second education program was emailed. This focused on how to use CPAP, potential benefits, methods of acclimating, and equipment care instructions. Education sessions were interactive and self-paced.

Tel-TM: Intervention based on automatic processing of device data. During the 3-month study period, if CPAP usage thresholds were met, a message was automatically sent to the patient providing encouragement to improve use or positively reinforcing successful adherence.

Tel-both: Patients received Tel-Ed and Tel-TM

Study Duration: 90 days

N=1455 patients with suspected OSA were randomised to four study arms, by class-based (cluster) randomised design.

This study used the existing home-based testing triage structure at the trialists institution. As they report, “Most patients are referred by primary care physicians, and a sleep medicine physician triages appropriate patients to home sleep apnoea testing (HSAT) after review of the referral information and electronic health record chart. HSAT classes (up to 13 people) are led by a sleep trained respiratory therapist and sleep technologist and provide interactive OSA education and individualized HSAT setup. After a one-night test, each patient returns for an individual appointment with a respiratory therapist to review the results. Those with OSA are recommended to undergo a 1-week CPAP trial followed by an individual return appointment with a respiratory therapist to review CPAP data and patient experience. Patients willing to commit to CPAP therapy is immediately dispensed a device; otherwise CPAP troubleshooting or alternative treatments are discussed." This trial enrolled Consecutive patients referred to the Kaiser Permanente Fontana Sleep Disorders Centre (Fontana, CA) for evaluation of suspected OSA and triaged to HSAT between November 2014 and August 2015. To conform to the sleep centre’s usual care procedures, groups of patients were randomised, with all participants in each HSAT class following the same treatment arm.

Inclusion criteria: At least 18 years of age, no previous sleep testing or trial of OSA therapy, eligible for HSAT.

Exclusion criteria: At risk of other sleep disorders (e.g., severe insomnia), significant cardiopulmonary disease (e.g., heart failure, chronic respiratory failure), or English not preferred language.

Baseline Characteristics: 51% female. Mean age 49.1 (±12.5). Mean AHI 22.7. Mean ESS 9.1. Mean BMI 34 kg/m².

CPAP usage (hours/night) at 90 days
Sleepiness (ESS)
Residual AHI
Number of adherent participants (Medicare definition, usage ≥ 4 h per night)
QoL (FOSQ)

Included in Cochrane review

Trialists included three intervention arms. One arm was educational (Tel-Ed), one was Supportive (Tel-TM) and the third was Mixed (Tel-Both). These were compared to control in respective meta-analyses (i.e., Educational, Supportive, Mixed).

Severe OSAHS based on mean AHI

Kotzian 2019⁴³

RCT

Austria

(n=70) Intervention 1: tele medical monitoring system to improve CPAP adherence.

All patients referred to PAP therapy received a 30 min introductory lesson with nasal or oro-nasal mask fitting, device handling and information about PAP therapy. Patients were provided with an AirSendse 10 Autoset CPAP including humidifier and were set to auto-titrate at pressures between 6 and 13 cm H20.

The PAP coordinator at the homecare provider reviewed the downloaded information every morning except on weekends and holidays and contacted the patients if the 90^th percentile of pressure was >16 com H20 or mask leakage of the 95^th percentile was >24l/min or use was <4h or the AHI was >10 events/h for three consecutive days.

(n=181) Intervention 2: Standard PAP treatment.

No tele medical monitoring system

Subacute adult (19-70 years of age) stroke survivors (>1 months to <1 year post stroke) with a completed stroke confirmed by a neurologist based on the history of a sudden onset of a neurological deficit lasting longer than 24 h, the presence of a neurological deficit upon physical examination, and a brain lesion compatible with the neurological deficit in computerised tomography or MRI of the brain were included. For evaluation of OSA, eligible patients underwent in hospital sleep studies. Therapy relevant OSA was defined as showing an AHI >15 per hour of sleep, indicating moderate sleep apnoea.

Age: telemonitoring: 62.9 (5.3 years); control: 61.8 (5.3) years

Gender: male: telemonitoring 64.7%: control: 75%

BMI: telemonitoring: 30.9 kg/m² (4.8): control: 29kg/m² (3.1)

AHI: telemonitoring: 37 (14.1): control: 37 (12.8)

Days PAP used >4 h- new outcome
AHI
Mean adherence all days (min per day)-new outcome

Follow-up 12 months

Severe OSAHS based on mean AHI

Lai 2014⁴⁶, Lai 2017⁴⁴

Randomised, parallel-group study

Country: China (Hong Kong)

Participants were randomised to usual care (UC, n=51) or UC + brief motivational enhancement program (ME, n=49).

UC: Usual Care: Usual care was provided by nurses in the Sleep Disorders Center who provided a 15-min talk to introduce the basic operation of the CPAP device and titration procedure. Subjects tried the CPAP device for approximately 30 min for acclimatization before the start of the overnight titration procedure. The next morning after CPAP titration, the subject met the medical officer-in-charge, who provided an explanation of OSA, explained the subject’s particular test results, and prescribed treatment. Nurses gave further advice (about 15 min) on the importance of CPAP therapy and care of accessories before the subjects were given their devices and discharged from the Sleep Disorder Center.

ME: Brief Motivational

Enhancement Education: The aim of brief motivational enhancement education is to enhance those factors that may influence behavioural skills and bring about behavioural change.

The brief motivational enhancement education programme, which was designed to enhance the subject’s perception of the risk of OSA, confidence in the ability to apply CPAP treatment (self-efficacy), and association of their behaviour to the desired outcome (adherence) or outcome expectancy, included a session in the morning after CPAP titration and a telephone call on day 2 of CPAP use, providing early follow-up.

The subject was shown a 25-min video together with an information booklet providing the knowledge on OSA and CPAP. The video included the real-life experience of a current CPAP user. Then, a 20-min patient centred face-to-face brief motivational interview was conducted and aimed to facilitate the subject’s intrinsic motivation toward CPAP therapy.

Several tools and strategies were applied, which were as follows:

(1) using importance and confidence rulers with higher-lower exercise to explore the barriers and facilitators of using CPAP (2) using a decision matrix to discuss the positive and negative aspects of using or not using CPAP, and (3) looking forward to the expected outcomes or benefits of using CPAP.

The interview was conducted by one of the investigators who was both a nurse and polysomnographic technologist who had received prior training to conduct motivational interviews by a clinical psychologist (member of Motivational Interviewing Network of Trainers).

Thereafter, a 10-min phone call was made to the subjects by the same interviewer on day 2 of CPAP use. Checklists for interview and phone follow-up were used to ensure treatment fidelity.

Duration: 3 months.

N=100 patients with newly diagnosed OSA.

Inclusion Criteria: At least 18 years old, newly diagnosed OSA, AHI >= 5, receiving in-laboratory auto-CPAP titration for the first time, no prior OSA or CPAP education classes.

Exclusion criteria: central sleep apnoea, periodic leg movement disorders, COPD, pregnancy, psychiatric illness on treatment, cognitive impairment, illiteracy, unstable health conditions, unable to attend the education session before discharge from Sleep Disorders Centre, scheduled for OSA follow-up in other hospitals, or participating in another clinical trial.

Baseline Characteristics: 17% female. Mean age 51.98 (±10). Mean AHI=29.42. Mean ESS=9.25. Mean BMI=28.96 kg/m².

CPAP usage (hours/night) at 1 and 3 months.
Number of adherent participants (usage ≥ 4 h per night for at least 70% of nights)
Sleepiness (ESS)
QoL (FOSQ, CSAQLI, SF-36)
ESS

Follow-up 3 months and 1 year

Included in Cochrane review

Moderate OSAHS based on mean AHI

Lewis 2006⁴⁷

Prospective, single-blinded interventional study

Country: UK

Participants were randomised to standard support (SS, n=36) or intensive support (IS, n=36) group.

IS: 20-Minute educational video about SAHS. Telephone interview by research assistant between days two and five after CPAP issued to identify early problems and advise. Extra appointment to see sleep physician within seven to 14 days after being issued CPAP. Further appointment with sleep physician at 1, 6, and 12 months

SS: Participants provided telephone number for support within office hours. Sleep physician reviewed participants at 1, 6, and 12 months

Study duration: 52 weeks

N = 72 patients with newly diagnosed SAHS immediately prior to CPAP titration.

Inclusion criteria: diagnosis of OSA (based on home sleep study) and subjective daytime sleepiness

Exclusion criteria: not reported

Baseline Characteristics: 13.8% female. Mean age 51.4 (±8.6). Mean AHI 42.5. Mean ESS 15.7. Mean BMI 36.5 kg/m².

Machine usage
Side effects
Satisfactions

Included in Cochrane review

Only 20/36 participants in the intervention group watched the educational video tape. Eight of the 17 defaulters returned machines at different times of the year and had negligible hours of use.

Severe OSAHS based on mean AHI

Mendelson 2014⁵³

Randomised, parallel-group study.

Randomization was stratified by recruitment centre in blocks of 6 participants.

Country: France

Participants were randomised to telemedicine (n=54) or standard care (n=53).

Standard Care: Evaluated at baseline, fitted with a nasal mask and given an auto titrating machine. Patients were contacted after 2 days to ask about adherence and to troubleshoot. After 4 weeks of treatment, patients met with their sleep specialist and data downloaded from machines. After 4 months of treatment, patients consulted their sleep specialist and were re-evaluated.

Telemedicine: In addition to standard care, TM participants were equipped with a smartphone for uploading BP measurements, CPAP adherence, sleepiness, and quality of life data. They received daily pictograms containing health-related messages.

Study Duration: 4 months.

N=107 patients with OSA and a high cardiovascular risk (cardiovascular SCORE > 5% or secondary prevention).

Inclusion Criteria: Age between 18 and 85 years, diagnosed with OSA on diagnostic sleep study (AHI > 15), BMI of less than 40 kg/m², cardiovascular risk SCORE > 5%, or being in secondary prevention with a past history of cardiovascular disease.

Exclusion criteria: Central sleep apnoea syndrome cardiovascular score < 5%, cardiac failure, history of hypercapnic chronic respiratory failure, incapacitated patients, pregnancy or taking part in another clinical trial.

Baseline Characteristics: 16.8% female. Mean age 63 (±9). Mean AHI=39. Mean ESS=7.9. Mean BMI=29.9 kg/m².

Home self-measured blood pressure (BP)
CPAP usage (hours/night)
Sleepiness (ESS)
QoL (SF-36)

All outcomes were measured at 4 months only.

Included in Cochrane review

Severe OSAHS based on mean AHI

Meurice 2007⁵⁴

Randomised parallel-group trial.

Country: France

Participants were randomised to Intervention Group 1 (n=27), Group 2 (n=27), , Group 3 (n=27) or Group 4 (n=26), defined as follows:

Intervention Group 1: RP + RH

Intervention Group 2: RP + SH

Intervention Group 3: SP + RH

Intervention Group 4: SP + SH (Control)

Reinforced education by Homecare Network (RH): Home visit by technician at installation and further visits for explanation at one week, one month and two and three months of treatment for repetition of education and problem solving

Reinforced education by prescriber (RP): Written material on CPAP use; explanation of OSA and CPAP with side effects; emphasis on importance of compliance with CPAP and detailed demonstration

Standard education by the homecare network (SH): Homecare visit to supply the CPAP machine fit the mask and explain the technique of using the apparatus. CPAP mechanism and method of using the machine and mask were explained. Participant was encouraged to ask questions and could phone at any time to resolve problems

Standard education by the prescriber (SP): Standard oral explanation of OSA and CPAP, brief demonstration of machine use plus manufacturer’s literature. Participant was encouraged to ask questions and clarify misunderstandings.

Study duration: 3 months, per protocol. Follow-up to 52 weeks (intervention administered at outset of study). Data extracted at three months. Authors report ‘During the remaining 9 months following the initial study design, there was no specific follow-up protocol and patients benefited from the standard homecare surveillance recommended in the ANTADIR network, with a review every 3 months’.

N=112 participants with severe OSA and no prior treatment for OSA.

Inclusion Criteria: PSG-confirmed OSA (AHI > 30), no prior OSA treatment, treated with constant pressure.

Exclusion criteria: None reported.

Baseline Characteristics: Mean age 58 (±11). Mean AHI=58(±25). Authors reported mean ESS and BMI by intervention arm and reported no significant differences. Gender distribution not reported.

CPAP usage (hours/night) at 3 months (6 and 12 months data also presented but outside study protocol time period).
Sleepiness (ESS)
Quality of life (SF-36)

Included in Cochrane review

Intervention groups 1, 2 and 3 combined for comparison to Control group (4) in Meta-Analysis, as recommended in Cochrane Handbook section 16.5.4.

Severe OSAHS based on mean AHI

Munafo 2016⁵⁶

Randomised, parallel-group study.

Country: USA

Participants were randomised to standard of care (SOC, n=64) alone, or SOC + web-based automated telehealth messaging program (TH, n=58).

SOC: Patients were dispensed a CPAP device on Day 0, then contacted via phone on Days 1, 7, 14, 30, and 90. CPAP usage and efficacy data were tracked via the wireless modem attached to CPAP machine. Modem data were accessed via online platform. Frequent phone calls and return clinic visits were provided, as necessary.

TH: CPAP device dispensed on Day 0, along with a pamphlet about U-Sleep, a web-based application to monitor adherence and message patients and providers via automated series of text messages/emails were triggered by pre-set conditions.

Study Duration: 3 months

N=122 newly diagnosed patients with OSA.

Inclusion criteria: Age 18–80 years, CPAP-naïve, confirmed OSA (AHI 5–70) diagnosis based on polysomnography (PSG) or home sleep test, access to and be able to utilize communication technology (text messaging, e-mail).

Exclusion criteria: prominent central apnoea (>20 %), claustrophobia, current use of mandibular repositioning device, other OSA therapy.

Baseline Characteristics: 31% female. Mean age 51.2 (±11.2). Mean AHI=30.4. Mean ESS=10.5. Mean BMI=33.2 kg/m².

CPAP usage (hours/night) at 90 days
Number of adherent participants (Medicare: use for >= 4 h/night on 70 % of nights during a 30 consecutive-day period anytime during first 90 days of initial usage)
Sleepiness (ESS)
Residual AHI

All outcomes measured at 90 days.

Included in Cochrane review

Severe OSAHS based on mean AHI

Murase 2020⁵⁷

RCT

Japan

(n=161) Intervention 1: Telemedicine group

Physician checked adherence data utilising the telemonitoring system.

Follow-every 3 months.

(3 months n= 166; 1 month, n=156) Intervention 2: No telemedicine

Follow-up 1 month and 3 months

N=508

The criteria for patient inclusion were >18 years old; fulfilled the requirements for CPAP treatment under Japanese governmental health insurance (AHI>20/h by PSG or respiratory event index >40/h by portable monitoring device at OSA diagnosis; CPAP implemented more than 3 months previously; residual AHI under CPAP use<20/h; having clinic visits every month or every 2 months for follow-up of CPAP therapy; recent CPAP adherence data available.

Age: telemedicine group: 60 (11); control: 60 (13) years

AHI: telemedicine: 40.6; control 40.6

Gender: male%: telemedicine 87%; control 86.1%

BMI: telemedicine: 27.4 kg/m² (3.8); control: 27 kg/m² (5.4)

Sleepiness: ESS: telemedicine 5.7 (4.0); 4.9 (2.3)

CPAP use min/night

Severe OSAHS based on mean AHI

Nilius 2019⁶¹

RCT

Germany

(n=37) Intervention 1: telemedicine

Therapy was uniformly initiated in all eligible patients that is after a positive PSG. Patients were visited by sleep lab staff, and a training session and mask adjustment followed before the initial therapy PSG. The device used was usually an APAP device set to a pressure 4-18 cm H20.

The online data for the telemedicine group was anonymously transferred to the password protected web server each morning. The data was evaluated for relevant therapy details each week starting 7 days after the individual discharge date of each patient.

(n=38) Intervention 2: No intervention – Standard care All patients went home with a PAP device and the sleep lab informed the homecare provider about the therapy settings and equipment. The patients were advised to visit their primary care physician or lung specialist if they experienced any problem.

Follow-up 6 months

(n=80)Patients who had suffered an ischaemic stroke within last 3 months; a moderate to severe baseline OSA with an AHI>15, that had been confirmed in the sleep laboratory; physical capability to operate a PAP device and mask; age<75;CPAP naïve; no COPD; and regular PAP usage (<3h/night) during the inpatient phase.

Age: telemedicine 55.4 (10.4) years; control: 58.6 (9.3) years

Gender: all females

BMI: telemedicine 31.7 kg/m² (5.4); control 30.1 kg/m² (6.6); Sleepiness

ESS: telemedicine 2.4 (3.7); 3.9 (4.9); AHI: 41.2 (19); control: 37.6 (18.4)

Usage hours/night-added to outcome
ESS- end point added to outcome
SF-12 physical
SF-12 mental
Systolic blood pressure
Diastolic blood pressure

Severe OSAHS based on mean AHI

Olsen 2012⁶²

Randomised parallel-group study

Country: Australia

Participants were randomised to motivational interviewing intervention (MINT, n=53) or control (n=53) group.

MINT: Motivational interview nurse therapy (MINT)

Three sessions of CPAP-specific Motivational Interview Nurse Therapy (MINT) one month apart. Each session lasted approximately 30 minutes. Participants were followed up at two to four weeks by physician and at two months by a nurse. A questionnaire and a machine meter data on adherence were obtained at one, three and 12 months.

The manual was initially informed by the Motivational Enhancement therapy manual developed by Miller and colleagues but with significant modification to increase the relevance to OSA population. As well as receiving general feedback about OSA severity, patients were provided feedback on their own responses to a satisfaction with life scale and apperception of functional severity questionnaire completed at baseline.

Sessions 1 and 2 were approximately 30 min in duration (maximum 45 mins), and the booster session was approximately 20 min in length (maximum 30 min). Participants were encouraged to bring along a significant other to the two initial MINT sessions.

Nurse training

Three nurses with 2-16 years specific sleep medicine training delivered the intervention. The nurses underwent a full day training session with a registered psychologist trained in clinical, health, sleep and neuropsychology. The nurse training session was a structured protocol based on the manual used for this intervention. The training day was Video recorded.

Control: Standard one-on-one 45-minute education session conducted on the day of CPAP titration. Participants were followed up at two to four weeks by physician and at two months by a nurse

Study duration: 52 weeks

N = 100 with OSA diagnosed by PSG.

Inclusion criteria: OSA confirmed by polysomnography, age ≥ 18, naive to CPAP

Exclusion criteria: need for bi-level ventilation, failed to complete CPAP titration, severe depression

Baseline Characteristics: 31% female (41.5% intervention, 28.3% control).

Mean age 56.6 (±11.0).

Mean RDI 34.3. Mean ESS 21.9. Mean BMI 34.5 kg/m².

CPAP acceptance and adherence
FOSQ
ESS

Included in Cochrane review

Severe OSAHS based on mean RDI

Parthasarathy 2012⁶⁴

Randomised parallel-group open-label

Country: USA

Participants were randomised to usual care (UC, n=17) or peer buddy system (PBS, n=22) group.

PBS: Trained peers with OSA and good CPAP adherence record were paired with newly diagnosed participants over three months. During two face-to-face sessions and eight telephone-based conversations, trained peers shared their experiences on coping strategies with CPAP, knowledge of perceived vulnerabilities of untreated OSA, motivated participants and promoted methods for improving efficacy of CPAP

UC: CPAP initiation and education class, participants were asked to send CPAP adherence ‘smart cards’ and were followed up at one and three months

Study duration: 90 days

N = 39 veterans with OSA prescribed CPAP.

Inclusion criteria: age 21-85, new diagnosis of OSA, AHI > 5, full night or split night polysomnography, no sedative medications used

Exclusion criteria: central or complex sleep apnoea, requirement of oxygen or Bi-PAP, unstable medical co-morbidities, irregular lifestyle pattern, excess alcohol use

Baseline Characteristics: 0% female. Mean age 52 (±14). Mean AHI 37. Mean ESS 10.8. Mean BMI 34 kg/m².

CPAP adherence
Functional Outcomes of Sleep Questionnaire (FOSQ)

Included in Cochrane review

Additional information on study methods and mean CPAP adherence obtained from the study author. These data were available from a pilot study.

Severe OSAHS based on mean AHI

Pengo 2018⁶⁵

Randomised, parallel-group study.

Country: UK

Participants were randomised to receive, in addition to CPAP therapy, either positively (n=36) or negatively framed (n=37) messages, or standard care (n=39) alone.

All patients received 2 weeks of APAP, followed by 4 weeks of fixed CPAP.

Standard care: Included explanation of importance of treating OSA, APAP introduction by expert sleep technicians, standard instructions on use of devices, review for troubleshooting, and compliance assessment at 2-weeks post treatment initiation.

Positive: Positively framed messages in addition to CPAP. Patients were phoned weekly and read the framed health messages (up to a total of 6 phone calls per patient).

Negative: Negatively frames messages in addition to CPAP. Patients were phoned weekly and read the framed health messages (up to a total of 6 phone calls per patient).

Study Duration: 6 weeks

N=112 patients who had positive home-based pulse oximeter screen for OSA.

Inclusion Criteria: Following at-home screening using nocturnal pulse oximetry, patients who had 4% ODI ≥5 and typical symptoms of sleep apnoea (ESS>10 points), or a 4% ODI > 15 were invited for CPAP treatment.

Exclusion Criteria: Mental or physical disability precluding compliance with study protocol, unable to participate in trial follow-up.

Baseline Characteristics: 25% female. Mean age 49.1 (±12.1). Mean ODI=24.8. Mean ESS=11.3. Mean BMI=36.5 kg/m².

CPAP usage (hours/night) at 6 weeks.
% Days CPAP used for > 4 hours
Sleepiness (ESS)

All outcomes reported at 2 and 6 weeks.

Included in Cochrane review

Intervention arms (positively- and negatively balanced messages) combined for comparison to Control arm in Meta-Analysis, as recommended in Cochrane Handbook section 16.5.4.

Moderate OSAHS based on mean AHI

Pepin 2019⁶⁶

Randomised, multi-centre parallel-group study.

Country: France

Participants were randomised to usual care (UC, n=149) or multimodal telemonitoring (TM, n=157) for 6 months.

TM: CPAP-related factors (adherence, leaks, and residual events), BP and physical activity recorded by connected devices. Symptoms and quality of life were recorded via electronic questionnaires completed by patients. Patients received demonstration home telemonitoring use and an explanation of why monitoring these physiological variables was relevant for their care. Automatic algorithms were constructed for the prompt adjustment of CPAP treatment.

UC: Received standard care usually received from their assigned sleep centres.

Study Duration: 6 months

N=306 patients with newly-diagnosed OSA.

Inclusion Criteria: 18 to 75 years, severe OSA (AHI > 30) on the basis of respiratory polygraphy or PSG, at least one cardiovascular disease or exhibit an elevated cardiovascular risk (Systematic Coronary Risk Evaluation risk > 5% at 10 years or in secondary prevention).

Exclusion Criteria: Central sleep apnoea, heart failure with a left ventricular ejection fraction < 40%.

Baseline Characteristics: 26% female. Median age 61.3 (IQR: 54.1-66.1). Median AHI=46. Median ESS=9. Median BMI=32.0 kg/m².

Systolic blood pressure [Author’s primary outcome]
CPAP usage (hours/night) at 6 months.
Sleepiness (ESS)
QoL (SF-12)

All outcomes were reported for 6-month endpoint only.

Included in Cochrane review

Severe OSAHS based on mean AHI

Richards 2007⁶⁹

Randomised, parallel-group trial

Country: Australia

Participants were randomised to treatment as usual (TAU, n=50) or Intervention (n=50) group.

Intervention: Cognitive-behavioural therapy. Two one-hour group sessions; slide presentation on sleep, OSA and treatment. CPAP machine on display and relaxation techniques in the event of anxiety caused by wearing CPAP mask Participants also benefited from video presentation with emphasis on perseverance with treatment and educational pamphlet made available

TAU: One standardised group education session; explanation of CPAP titration process; familiarisation with equipment used and procedure to be followed on the titration night. Explanation of side effects, all participants strongly encouraged to contact staff to obtain relevant help and support. Participants assessed and fitted with comfortable mask to be worn during titration

Study duration: 28 days

N = 100 participants with newly-diagnosed OSA referred for CPAP titration.

Inclusion criteria: Newly diagnosed with OSA referred for CPAP titration

Exclusion criteria: Inability to understand fluent English, previous use of CPAP.

Baseline Characteristics: 4% female. Mean age 56. Mean RDI 26.5. Mean ESS 10.5. Mean BMI 30.3 kg/m².

Machine usage

Included in Cochrane review

Severe OSAHS based on mean RDI.

Roecklein 2010⁷¹

Randomised parallel-group study

Country: USA

Participants were randomised to standard education (SE, n=16) or personalized feedback (PF, n=14) group.

PF: Written personalised feedback report, including detailed information on severity of the disease, self-reported daytime sleepiness, individually estimated risk of adverse health outcome and risk of motor vehicle accident, all compared with normative data. Feedback addressed barriers to using CPAP, ambivalence about treatment and difficulties of behaviour change and promoted self-efficacy and personal responsibility for choosing to use CPAP

SE (control): Written information from the American Academy of Sleep Medicine on OSA, Snoring and PAP therapy for OSA

Study duration: 3 months

N = 30 patients diagnosed with OSA by PSG, naive to CPAP and reporting intent to use CPAP.

Inclusion criteria: age 18 to 65, CPAP naive, reported intent to use CPAP (other sleep, psychiatric or health problems were not exclusion criteria)

Exclusion criteria: None reported.

Baseline Characteristics: 70% female. Mean age 46.3 (±11.2). Mean AHI 44.4. Mean ESS 11.6. Mean BMI 42.1 kg/m².

Objective CPAP usage (total hours, average hours/night, number of sessions)
Self-reported CPAP usage

Included in Cochrane review

Participants were not provided machines but obtained them ‘naturalistically’, most commonly through insurance. Most participants were low-income African Americans.

Severe OSAHS based on mean AHI

Sarac 2017⁷²

Randomised, parallel-group study.

Country: Turkey

Participants were randomised to receive standard support (SS, n=63) or educational support (ES, n=52).

SS: General explanation (~10-15 min) of OSA and PAP.

ES: SS + additional education (~ 20 min) by a sleep medicine physician , including: viewing his/her own polysomnography chart on morning post PAP-titration, comparing the PSG from diagnostic and CPAP titration studies with explanations that emphasized obstructive events and oxygen desaturations, and the disappearance of those signs on PAP treatment.

Study Duration: Approximately 6 months

N=115 patients with OSA.

Inclusion criteria (not explicit): ≥18 years old), newly diagnosed OSA (AHI ≥5), free from upper airway obstructions.

Exclusion criteria (not explicit): Not interested in PAP or in study participation, living outside Istanbul, unable to come to follow-up.

Baseline Characteristics: 24.5% female. Mean age 51 (±9.3). Mean AHI=41.4. Mean ESS=10.0. Mean BMI=32.5 kg/m².

CPAP usage (hours/night) at 5 time points, participants invited to return at 15, 30, 60, 90- and 180-days post-randomisation (actual time of measurements varied by participant)
Number of adherent participants (usage ≥ 4 h per night on at least 70% of nights) at short-term (first) and long-term (last) follow-up
Sleepiness (ESS)

Included in Cochrane review

58 out of 63 patients in the SS group, and 49 out of 52 patients in the ES group completed the five follow-up appointments during the study period. The median time from randomization to first follow-up was 20 days for both groups with an IQR 17–27 days for the SS group, and 16–26 days for the ES group (p=0.89). The median time to last follow-up was 187 days (IQR 170-202 days) in the SS group, and 184 days (IQR 173–198 days) in the ES group (p=0.16).

Severe OSAHS based on mean AHI

Sawyer 2017⁷³

Randomised, parallel-group study.

Country: USA

Participants were randomised to receive usual care (UC, n=57) or a multi-phased and tailored intervention (TI, n=61) targeting social cognitive perceptions of OSA–PAP treatment.

TI: Intervention addressed cognitive perceptions of the diagnosis and treatment, outcome expectancies with PAP treatment, and PAP treatment self-efficacy, all domains of SCT. Intervention delivered in four phases: pre-diagnosis, post diagnosis (i.e., post diagnostic polysomnogram), immediately post-PAP titration polysomnogram, and with week 1 of home PAP treatment. Intervention delivery guided by a protocol and script templates for specific exposure phases to minimize a potential interventionist effect.

UC: Followed current practice standards for the diagnosis and treatment of OSA in adults (Epstein et al., 2009; Kushida et al., 2006). Included sleep centre–provided informational brochures about OSA, diagnostic testing, and PAP prescription. In addition, access by telephone to sleep centre staff for problems, questions, or concerns was provided during daytime and evening.

Study Duration: 3 months

N=118 adults with newly diagnosed OSA Any adult patient referred for a diagnostic PSG was invited to participate in the study.

Inclusion Criteria: newly diagnosed with OSA (AHI > 10), PAP-naive, ≥18 years of age, able to read and speak English. Exclusion criteria: previous diagnosis or treatment of OSA; medical record documented new psychiatric diagnosis within previous six months of study enrolment; requirement of supplemental oxygen or bi-level PAP identified on PAP titration PSG suggesting diagnosis other than OSA; diagnosis of another sleep disorder in addition to OSA based on polysomnogram (i.e., periodic limb movement disorder [≥10 limb movements/hr of sleep with arousal], central sleep apnoea [≥5/hr central apnoea’s], insomnia, sleep hypoventilation syndrome, or narcolepsy).

Baseline Characteristics (per-protocol): 30% female. Mean age 51.3 (±11.1). Mean AHI=36. Mean ESS=19.6. Mean BMI=38.0 kg/m².

CPAP usage (hours/night) at 1 week, 1 month and 3 months.
Number of adherent participants (usage ≥ 4 h per night) at 1 week, 1 month and 3 months.

Severe OSAHS based on mean AHI

Scala 2012⁷⁴

Randomised, parallel-group study. *** FULL INFORMATION PENDING TRANSLATED FULL TEXT ***

Country: Italy

Participants were randomised to standard care (SC, N=15) or an educational intervention (EDU, N=13).

EDU: 3 interactive sessions, video with discussion, focus group and role play, respectively 1, 2 and 3 months after receiving the CPAP device.

Study Duration: 6 months

N=28 patients with newly-diagnosed OSAS.

Inclusion Criteria: Newly-diagnosed, OSAS.

Exclusion criteria: Not reported.

Baseline Characteristics: 75.3% female. Mean age 57 (±11.2). Mean AHI NR. Mean ESS 12.6. Mean BMI NR.

CPAP usage (hours/night) at 6 months (12-month results pending at time of report)
Sleepiness (ESS)
QoL (SF-36)

Outcomes measured at 6 months.

Included in Cochrane review

Sedkaoui 2015⁷⁷

Randomised, parallel-group study.

Country: France

Participants were randomised to standard support (SS, n=190) or coached support (CS, n=189).

SS: Received information from their physician about modalities and usefulness of CPAP treatment. Technician performed CPAP set-up at participant’s home, re-explained the device’s function, and checked for mask fit and adaptation. Follow-up performed at 1 month and 4 months to assess CPAP parameters.

CS: In addition to SS, participants in CS received standardized support completed through 5 sessions (day 3, 10, 30, 60, and 90) via telephone-base counselling. Session 1 objective was to assess patient’s knowledge about the disease, device and health consequences; to emphasises importance of good adherence; to encourage CPAP use throughout sleep every day. Objectives of the other educational sessions were to identify disadvantages or obstacles CPAP treatment and then focus on the benefits linked to use of CPAP. A particular effort was made to discuss misconceptions about sleep apnoea and barriers to use, concerns fears and beliefs, as well as the perceptions of their partners and family, in order to increase patients’ positive expectations regarding CPAP benefits.

Study Duration: 4 months

N=379 with newly diagnosed SAHS

Inclusion Criteria: OSAHS, prescribed CPAP, AHI ≥ 30 or AHI < 30 and > 10 arousals/hour, French fluency.

Exclusion criteria: Age <18 years, under guardianship, previous CPAP use, psychiatric illness, participating in another clinical trial

Baseline Characteristics: 72.0% female. Mean age 63. Mean AHI 42.2. Mean ESS 11.6. Mean BMI 40 kg/m².

CPAP usage (hours/night) at 4 months
Number of adherent participants (usage ≥ 3 h per night) at 4 months

Included in Cochrane review

Severe OSAHS based on mean AHI

Shapiro 2017⁷⁸

Randomised parallel-group trial

Country: USA

Participants were randomised to standard care (SC, n=33) or CPAP-SAVER Intervention (CI, n=33).

SC: Basic OSA and CPAP teaching and follow-up provided by respiratory therapist/CPAP education employed by home medical supplier.

CI: Standard care plus airway model, video education sheet, report card components, support calls.

N=46 newly-diagnosed with OSA and prescribed CPAP for the first time.

Inclusion criteria: >= 18 years; newly-diagnosed by PSG; commencing CPAP for first time; able to read/speak/understand/write English; CPAP with smart card technology

Exclusion criteria: requires BiPAP, significant craniofacial abnormalities, Downs syndrome, cognitive delay, hypertonia, neuromuscular degenerative disorder, taking anti-anxiety medication, pregnant.

Baseline Characteristics: 45.5% female, Mean age 51.8 (13.1). Mean AHI 26.2. Mean ESS NR. Mean BMI 35.7kg/m².

CPAP usage (hours/night) at 1 month

Included in Cochrane review

Moderate OSAHS based on mean AHI

Smith 2006⁸²

Randomised parallel-group trial

Country: USA

Participants were randomised to control (n=9) or intervention (n=10) group.

Intervention: Two-way telehealth sessions mediated by video link-up through phone line. Research nurse emphasised nightly, bedtime routine for CPAP. After standardised protocols, nurse visually assessed participant, guided correct CPAP routine and determined whether the CPAP mask fits properly. Nurse described consequences of non-adherence and managing barriers to CPAP use. Benefits of nightly CPAP use for general health were emphasised

Control: Two-way telehealth sessions mediated by video link-up through phone line. Protocols drawn up to mimic content delivered to intervention group. Instead of CPAP-related information, participants given content on vitamin intake

Study duration: 12 weeks

N = 19 with newly-diagnosed OSA, non-adherent with CPAP for 3 months

Inclusion criteria: New OSA diagnosis, first CPAP prescription, received initial education on CPAP use and supplemental audiotaped/videotaped reinforcement at two and four weeks, non-adherent with CPAP for 3 months

Exclusion criteria (unclear if a priori): positive screen for drug or alcohol abuse, depression requiring hospitalization

Baseline Characteristics: % female NR. Mean age 63 (±8). Mean AHI NR. Mean ESS NR. Mean BMI NR.

Number of adherent participants (usage ≥ 4 hrs/night on ≥ 9 of 14 nights) at 12 weeks

Included in Cochrane review

Non-adherence in the study defined as less than four hours of CPAP use per night for fewer than nine of 14 consecutive nights’ use TJL emailed for details of randomisation and outcome data 12/09/2008. Carol Smith responded 15/09/2008. For updated review, further email communication was required to verify that updated inclusion criteria were met, confirmation received from Carol Smith, 27mar2019.

Smith 2009⁸¹

Randomised parallel-group trial

Country: USA

Participants were randomised to control (n=42) or CPAP Habit Intervention (Intervention, n=55) group. All participants received usual education on OSA and demonstration of CPAP equipment

Intervention: The Habit-Promoting Experimental Audio

Intervention: CPAP Every Day—The CPAP intervention packet called, “Get in the Habit of CPAP Every Day,” included audiotaped music along with softly-spoken directions for using CPAP nightly. The sleep inducing audio music entitled, “Building a Routine for Sleep Time.” The audio music guided patients in preparing the CPAP machine at bedtime and in creating a relaxing environment in congruence with music and lyrics. The 20-minute audio provides instructions for putting on the CPAP mask comfortably, correctly connecting air hoses and relaxing despite the ventilation equipment positive air pressure and noise. The audio first instructs the patient to practice breathing in deeply and then exhaling slowly for relaxation. Next, the patient is guided to relax his or her muscles slowly from toes to head, using repeated reminders for slow, deep breathing and spoken images of long restful sleep (e.g., “feel the gentle air pressure slowly filling your lungs”) to sensitize patients to CPAP benefits. The gradually decreasing music tempo induces relaxation by slowly reducing the rhythms to a typical resting heart rate cadence.

The intervention packet had informational handout sheets, CPAP use reminder placards and a 4-week diary for recording CPAP use. The diaries have pages for recording audio use and writing about their experiences with CPAP. Handouts in the packet list the health consequences of not using CPAP, such as the high risk of stroke and heart attack, falling asleep while driving, poor functioning on work activities due to sleepiness, or missing out on social activities due to fatigue or tiredness and an audio disc, including music that relaxes patients into sleep.

Materials also provided information about benefits of adherence (increased alertness, energy for activities, less irritability). Thus, the intervention integrated CPAP benefit and non-use risk information, music relaxation and habit-promoting instructions as a guide to routine nightly use of CPAP].

Control: Audiotaped music along with spoken information about vitamins. Information packet was the same in format and length as the intervention group, but content was on vitamins

Study duration: 6 months

N = 97 patients with newly-diagnosed OSA.

Mean age: 63.4, Male sex: 55%, Mean AHI: Intervention group: 52.3, Control group: 47.3

Inclusion criteria: new diagnosis of OSA, age ≥ 18, AHI ≥ 20

Exclusion criteria (unclear if a priori): positive screen for drug or alcohol abuse, depression requiring hospitalization

Baseline Characteristics: 45% female. Mean age 63. Mean AHI 50.1. Mean ESS NR. Mean BMI NR.

Number of participants adhering to CPAP (≥ 4 hours/day and ≥ 9 of 14 nights) at 1, 3 and 6 months

Included in Cochrane review

Severe OSAHS based on mean AHI

Soares-Pires 2013⁸³

Randomised, parallel-group study.

Country: Portugal

Education group: Participants were assigned to a single group education session one month after beginning APAP therapy. Sessions were conducted by a pulmonologist, a psychologist, and a respiratory physiotherapist. Sessions included information regarding OSAHS, its symptoms and risks, APAP treatment, the importance of good adherence, and different machine interfaces. Patients were invited to share their experience on the use of APAP, and each patient’s adherence reports were analysed and discussed. Patients; concerns, fears, and beliefs were also addressed.

Standard Care: The sleep physician provided a brief explanation of the disease to patients of both groups, as well as informed patients of the need for APAP treatment, its benefits and function mode. None of the patients had previously received any form of PAP therapy. Approximately 3–5 days after the prescription, technicians from the PAP systems delivery companies performed a home visit to drop the APAP device. In this visit, an explanation on how to turn on and off the machine and on the placement of the interface was provided to all patients.

Study Duration: 6 months

N=202 patients with OSAHS.

Inclusion criteria: AHI ≥15 or ≥5 events per hour plus symptoms that included unintentional sleep episodes while awake, daytime sleepiness, unrefreshing sleep, fatigue, insomnia, gasping or choking, or loud snoring and/or apnoea described by the patient’s bed partner.

Exclusion criteria: lung disease, obesity hypoventilation syndrome, restrictive ventilatory syndromes, long-term oxygen therapy, Cheyne–Stokes breathing pattern, central apnoea, cognitive disability.

Baseline Characteristics: 29.5% female. Median age 58.5. Median AHI 38. Median ESS 12. Median BMI 32 kg/m².

CPAP usage (hours/night) at 6 months.
Number of adherent participants (usage > 4 h/night for ≥ 70% days

Severe OSAHS based on mean AHI

Sparrow 2010⁸⁴

Randomised parallel-group trial

Country: USA

Participants were randomised to control (n=126) or interactive voice response system, TLC-CPAP (TLC-CPAP, n=124) group.

TLC-CPAP: (telephone-linked communications for CPAP (TLC-CPAP), (n=124) The TLC-CPAP was designed around the concepts of motivational interviewing, a patient-centred approach to increase motivation to engage in a health behaviour by addressing the themes of perceived importance of using CPAP and confidence to adhere to CPAP. The TLC-CPAP system was automated and adapted from the intervention described by Aloia et al as Motivational Enhancement for CPAP. TLC-CPAP uses digitised human speech to speak to the patients and the patients communicate via the touch-tone keypad of their telephones.

The TLC-CPAP content includes assessment of the patient’s perceptions about and experiences with OSAS and CPAP therapy and the patient’s reported CPAP use (hours per night and nights per week) during the week preceding each call; assessment of the patient’s goals with regard to OSAS therapy; and feedback and counselling to enhance motivation to use CPAP and address barriers and poor self-efficacy. Participants were required to make weekly calls to TLC-CPAP during the first month beginning 3 days after starting CPAP therapy and thereafter monthly for the 12-month duration of the study. The computer system called the participants if they did not make a call at the expected times (some grace time was allowed).

Control: Attention placebo control’ group received general education on a variety of health topics via a telephone-linked communication (TLC) system. Participants were required to make calls on the same schedule as the intervention group

Study duration: 12 months

N = 250 patients undergoing initial set-up of fixed-pressure CPAP or BiPAP.

Inclusion criteria: Age 18 to 80 years, AHI > 10

Exclusion criteria: Not reported

Baseline Characteristics: 18% female. Median age 55. Median AHI 38.3. Median ESS 10.5. Median BMI 35.1 kg/m².

Machine usage (data downloaded from memory cards or by direct interrogation of CPAP devices) at 6and 12 months.
Number of adherent participants (usage > 4 h per night)

Included in Cochrane review

Severe OSAHS based on mean AHI

Stepnowsky 2007⁸⁶

Randomised parallel-group trial

Country: USA

Participants were randomised to usual care (UC, n=24) or telemonitoring (TM, n=21) group.

TM: Review of compliance and efficacy data. Monitored information garnered as objective compliance data and subjective reports of usage. Follow-up tailored to how CPAP used by participants. Details on how many total hours the PAP unit was used each night at therapeutic pressure. Efficacy data consisted of the amount of mask leakage (L/s) and the AHI (total number of apnoea/apnoea’s and hypopnoeas per hour of sleep)

UC: Telephone call from staff one week after CPAP initiation and office follow-up visit at one month. Participants encouraged to call clinic any time with problems or concerns

Study duration: 2 months

N = 45 patients newly-diagnosed with OSA.

Inclusion criteria: AHI ≥ 15, no prior CPAP treatment, stable sleep environment

Exclusion criteria: allergies/sensitivity to mask or mask material, previous use of any other PAP device (e.g. bi-level PAP, auto-adjusting PAP), current use of prescribed supplemental oxygen or significant comorbid medical conditions that could interfere with daily use of CPAP

Baseline Characteristics: 2% female. Mean age 59 (±14.3). Mean AHI 39. Mean ESS 12.6. Mean BMI 32.8 kg/m².

CPAP usage (hours/night)
% nights with CPAP use > 4 hours
Sleepiness (ESS)
QoL (FOSQ)
AHI

All outcomes reported at 2 months.

Included in Cochrane review

Severe OSAHS based on mean AHI

Stepnowsky 2013⁸⁵

Randomised parallel-group trial

Country: USA

Participants were randomised to telemonitoring (TM, n=126) usual care (UC, n=115) group.

TM: Main goals of MyCPAP intervention were to (a) allow both the patient and provider access to tele monitored adherence and efficacy data on a daily basis, (b) act on that data collaboratively to guide CPAP management and troubleshoot problems early and effectively, and (c) emphasize ways for the patient to express their preferences and needs

UC: Diagnostic sleep study, CPAP instruction and setup by trained health care provider, and follow-up at predetermined times (1-week, 1 month) by CPAP clinic staff. Beyond these pre-determined clinic contacts, patients were encouraged to call whenever they had a problem or concern.

Study Duration: 4 months

N=241 patients with a recent OSA diagnosis and prescription for CPAP therapy.

Inclusion criteria: Diagnosis of OSA (apnoea-hypopnea index ≥ 15), CPAP therapy prescription, and age ≥ 18 years.

Exclusion criteria: residence in a geographical area outside of San Diego County, fatal comorbidity (life expectancy less than 6 months as indicated by physician); or significant documented substance/chemical abuse.

Baseline Characteristics: % female NR (may be all male veterans). Mean age 52.1 (±13.3). Mean AHI 36.5. Mean ESS 10.6. Mean BMI 32.5 kg/m².

CPAP usage (hours/night) Sleepiness (ESS)
QoL (SAQLI)

Outcomes were reported at 2 and 4 months.

Included in Cochrane review

Severe OSAHS based on mean AHI

Turino 2017⁹²

Prospective randomised controlled trial.

Country: Spain

Participants were randomised to standard management (SM, n=48) or a telemonitoring programme (TM, n=52)

TM: Each CPAP device equipped with mobile 2G technology capable of sending daily information on CPAP adherence, CPAP pressures, mask leak and residual respiratory events to the web database. Automatic alarms for the provider were generated in case of mask leak >30 L/min for >30% of the night or usage of <4 h/night on two consecutive nights. In case of alarm, the pulmonary specialist medical officer of the CPAP provider contacted the patient, providing case-by-case problem solving.

SM: Patients were fitted with a mask and given a CPAP device and a leaflet explaining how to use it. A short instruction session on CPAP device use was provided to patients and partners in the sleep unit by a trained nurse. This included a practical demonstration of how to put on the mask, and the correct management and cleaning of the tubes, masks and humidifier. Information on how to turn the CPAP device on and off was provided by the homecare provider at the time of machine delivery. All patients were visited after 1 month of treatment by the nurse at the sleep unit.

N=100 newly diagnosed OSA patients

Inclusion criteria: >18 years, newly diagnosed OSA requiring treatment with CPAP (AHI >15).

Exclusion criteria: Impaired lung function (COPD-OSAHS overlap syndrome, obesity hypoventilation and restrictive disorders), severe heart failure, psychiatric disorders, periodic leg movements, pregnancy, other dyssomnias or parasomnias, history of previous CPAP treatment.

Baseline Characteristics: 23% female. Mean age 55 (NR). Mean AHI 52. Mean ESS NR. Mean BMI 35 kg/m².

Machine usage (hours/night) at 1 month, 3 months
QoL (EQ-5D)
Blood pressure

Included in Cochrane review

Severe OSAHS based on mean AHI

Wang 2012⁹⁵

Randomised parallel-group study.

Country: China

Participants were randomised to one of four arms: PMR+EDU (n=38), EDU (n=38), PMR (n=38), Control (n=38).

Education (EDU only): Three nights of CPAP titration in the first week, four-hour group education session on OSA and CPAP in the first week, participants were given a brochure describing benefits of CPAP and CD containing a 20-minute video demonstrating how to optimise CPAP treatment, 24-hour consultation telephone line to the sleep nurses was available

Progressive Muscle Relaxation Training (PMR only): One night of CPAP titration in the hospital, 12 × 40-minute group Progressive Muscle Relaxation (PMR) practice sessions over 12 weeks, one per week. Self-practice of PMR before each CPAP treatment. Brochure and CD with a guide for PMR practice at home.

EDU + PMR: Three nights of CPAP titration in the hospital. Combination of interventions as in Education and PMR group (see above)

Control: One night of CPAP titration in the hospital in the first week

Study duration: 12 weeks

N=152 participants with a new OSA diagnosis.

Inclusion criteria: new OSA diagnosis, AHI ≥ 10, above elementary school education, ‘conscious mind and able to communicate clearly’

Exclusion criteria: personal or family history of mental illness, drug or alcohol abuse, severe cognitive impairment, ‘concurrent oncologic or psychiatric diseases’

Baseline Characteristics: 6.8% female. Mean age NR. Mean AHI 43.1. Mean ESS=14.1. Mean BMI NR.

Authors did not report mean age for full sample or by intervention arm (reported only distribution Ns per (4) age groups for each arm). Also did not report average BMI for full sample or by intervention arm (reported only distribution Ns per (4) BMI groups for each arm).

CPAP usage (hours/night) at 4, 8 and 12weeks
Number of adherent participants (≥ 4 hours/night and at least 9 of 14 nights ventilator use) at 4, 8 and 12 weeks of intervention
Sleepiness (ESS)
QoL

Included in Cochrane review

Trialists included three intervention arms. One arm was Educational (EDU), one was Behavioural (PMR) and the third was Mixed (EDU+PRM). These were compared to control in respective meta-analyses (i.e., Educational, Behavioural, Mixed).

Severe OSAHS based on mean AHI

Table 3Clinical evidence summary: Behavioural therapy + CPAP versus control + CPAP- Severe OSAHS

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Control

Risk difference with Behavioural therapy + CPAP versus control + CPAP (95% CI)

CPAP Device Usage (hours/night)

Higher is better

577

(8 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, imprecision, indirectness

The mean CPAP device usage (hours/night) in the control groups was

3.32

The mean CPAP device usage (hours/night) in the intervention groups was

1.31 higher

(0.95 to 1.66 higher)

N deemed adherent (≥ four hours/night)

Higher is better

549

(6 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, imprecision, indirectness

RR 1.33 (1.1 to 1.61)

Moderate

408 per 1000

135 more per 1000

(from 41 more to 249 more)

Withdrawal

939

(10 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, imprecision, indirectness

RR 0.7 (0.51 to 0.98)

Moderate

81 per 1000

24 fewer per 1000

(from 2 fewer to 40 fewer)

Epworth Sleepiness Scale (Endpoint scores)

Lower is better

371

(6 studies)

⊕⊝⊝⊝

VERY LOW¹^,³^,⁴

due to risk of bias, inconsistency, indirectness

The mean ESS in the control groups was 9.0

The mean epworth sleepiness scale in the intervention groups was

2.22 lower^*

(3.68 to 0.75 lower)

AHI on treatment – Endpoint

Lower is better

(2 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, imprecision, indirectness

The mean AHI in the control group was 4

The mean ahi on treatment in the intervention groups was

0.95 lower

(2.25 lower to 0.35 higher)

Quality of Life - Comparison of Values at Endpoint - QoL: FOSQ – Endpoint

Higher is better

200

(2 studies)

⊕⊕⊝⊝

LOW¹^,⁴

due to risk of bias, indirectness

The mean quality of life - comparison of values at endpoint - QOL: FOSQ - endpoint in the control groups was

10.6

The mean quality of life - comparison of values at endpoint - QOL: FOSQ - endpoint in the intervention groups was

0 higher

(0.15 lower to 0.16 higher)

Quality of Life - Comparison of Values at Endpoint - QoL: SF-36 (PH) – Endpoint

Scale from 0-100

Higher is better

(1 study)

⊕⊕⊝⊝

LOW¹^,⁴

due to risk of bias, indirectness

The mean quality of life - comparison of values at endpoint - QOL: sf-36 (ph) - endpoint in the control groups was

78.1

The mean quality of life - comparison of values at endpoint - QOL: sf-36 (ph) - endpoint in the intervention groups was

1.1 lower

(11.46 lower to 9.26 higher)

Mortality (critical outcome)

Not reported

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by one increment if the confidence interval crossed one MID and downgraded by two increments if the confidence interval crossed both MIDs. MID for machine usage (adherence)- 1 hour; Established MIDs for SF-36 physical/mental- 2/3 ; FOSQ- 2 ; ESS −2.5;SAQLI - 2 . GRADE default MID (0.5XSD) used for all continuous other outcomes.
3: Downgraded by 1 or 2 increments for heterogeneity, unexplained by subgroup analysis. Random effect analysis used.
4: Downgraded by 1 or 2 increments because the majority of the evidence included an indirect or very indirect population respectively
*: Not sleepy in both groups

Table 4Clinical evidence summary: Educational interventions + CPAP versus usual care + CPAP- Severe OSAHS

Outcomes	No of Participants (studies) Follow up	Quality of the evidence (GRADE)	Relative effect (95 % CI)	Anticipated absolute effects
Outcomes	No of Participants (studies) Follow up	Quality of the evidence (GRADE)	Relative effect (95 % CI)	Risk with Control	Risk difference with Educational interventions + CPAP versus usual care + CPAP (95% CI)
CPAP Device Usage (hours/night) Higher is better	1128 (10 studies)	⊕⊝⊝⊝ VERY LOW¹^,²^,³^,⁴ due to risk of bias, inconsistency, imprecision, indirectness		The mean CPAP device usage (hours/night) in the control group was 3.5	The mean CPAP device usage (hours/night) in the intervention groups was 0.88 higher (0.4 to 1.36 higher)
N deemed adherent (≥ four hours/night) Higher is better	1019 (7 studies)	⊕⊕⊝⊝ VERY LOW¹^,³^,⁴ due to risk of bias, imprecision, indirectness	RR 1.31 (1.15 to 1.48)	Moderate
N deemed adherent (≥ four hours/night) Higher is better	1019 (7 studies)		RR 1.31 (1.15 to 1.48)	547 per 1000	170 more per 1000 (from 82 more to 263 more)
Withdrawal	1745 (9 studies)	⊕⊕⊝⊝ LOW¹^,⁴ due to risk of bias, indirectness	RR 0.73 (0.52 to 1.02)	Moderate
Withdrawal	1745 (9 studies)	⊕⊕⊝⊝ LOW¹^,⁴ due to risk of bias, indirectness	RR 0.73 (0.52 to 1.02)	150 per 1000	41 fewer per 1000 (from 72 fewer to 3 more)
Epworth Sleepiness Scale - Comparison of Values at Endpoint- Scale from 0-24 Higher is worse	355 (3 studies)	⊕⊝⊝⊝ VERY LOW¹^,³^,⁴ due to risk of bias, imprecision, indirectness		The mean ESS in the control group was 6.41	The mean epworth sleepiness scale scores in the intervention groups was 0.08 lower^* (0.92 lower to 0.76 higher)
Mortality (critical outcome)	-	-	-	-	Not reported

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 or 2 increments for heterogeneity, unexplained by subgroup analysis. Random effect analysis used.
3: Downgraded by one increment if the confidence interval crossed one MID and downgraded by two increments if the confidence interval crossed both MIDs. MID for machine usage (adherence)- 1 hour; Established MIDs for SF-36 physical/mental- 2/3 ; FOSQ- 2 ; ESS −2.5;SAQLI – 2. GRADE default MID (0.5XSD) used for all other continuous outcomes.
4: Downgraded by 1 or 2 increments because the majority of the evidence included an indirect or very indirect population respectively
*: Not sleepy in both groups

Table 5Clinical evidence summary: Increased practical support and encouragement during follow-up + CPAP versus usual care + CPAP - Severe OSAHS

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Control

Risk difference with Increased practical support and encouragement during follow-up + CPAP versus usual care + CPAP (95% CI)

CPAP Device Usage (hours/night)

Higher is better

1501

(14 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,³

due to risk of bias, inconsistency, imprecision

The mean CPAP device usage (hours/night) in the control group was

3.6

The mean CPAP device usage (hours/night) in the intervention groups was

0.83 higher

(0.45 to 1.22 higher)

Days PAP used >4 hours at 12 months

Higher is better

(1 study)

⊕⊕⊝⊝

LOW²

due to imprecision

The mean days pap used >4 hours in the control group was 282 days

The mean days pap used >4 hours at 12 months in the intervention groups was

11 lower

(75.76 lower to 53.76 higher)

Days PAP used >4 hours at 3 months

Higher is better

294

(2 studies)

3 months

⊕⊕⊕⊕

HIGH

The mean days pap used >4 hours in the control group was 65.8 days

The mean days pap used >4 hours at 3 months in the intervention groups was

8.06 higher

(1.80 to 14.33 higher)

Mean adherence all days (min per day) at 12 months

Higher is better

(1 study)

⊕⊕⊕⊝

MODERATE²

due to imprecision

The mean adherence all days (min per day) at 12 months in the control group was

307

The mean adherence all days (min per day) at 12 months in the intervention groups was

45 higher

(20.99 lower to 110.99 higher)

CPAP use min/night

Higher is better

327

(1 study)

⊕⊕⊕⊕

HIGH

The mean CPAP use min/night in the control groups was

307

The mean CPAP use min/night in the intervention groups was

20 higher

(1.51 lower to 41.51 higher)

N deemed adherent (≥ four hours/night)

376

(2 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, imprecision, indirectness

RR 1.19 (1.03 to 1.37)

Moderate

635 per 1000

121 more per 1000

(from 19 more to 235 more)

Withdrawals

1702

(11 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, imprecision, indirectness

RR 1.22 (0.97 to 1.52)

Moderate

118 per 1000

26 more per 1000

(from 4 fewer to 61 more)

Epworth Sleepiness Scale - Comparison Endpoint or Change from Baseline Values - ESS: Endpoint Scores

Scale from 0-24

Lower is better

1527

(15 studies)

⊕⊕⊝⊝

LOW¹^,³

due to risk of bias, inconsistency

The mean epworth sleepiness scale - in the control groups was

3.16

The mean epworth sleepiness scale - comparison endpoint or change from baseline values - ESS: endpoint scores in the intervention groups was

0.28 lower

(0.73 lower to 0.16 higher)

Quality of Life: Comparison of Values at Endpoint - QoL: FOSQ – Endpoint

Scale from 5-20

Higher is better

109

(3 studies)

⊕⊕⊝⊝

LOW¹^,⁴

due to risk of bias, indirectness

The mean quality of life: FOSQ - in the control groups was

16.1

The mean quality of life: comparison of values at endpoint - QOL: FOSQ - endpoint in the intervention groups was

0.55 higher

(0.81 lower to 1.9 higher)

Quality of Life: Comparison of Values at Endpoint - QoL: SAQLI – Endpoint

Higher is better

240

(1 study)

⊕⊕⊝⊝

LOW¹^,⁴

due to risk of bias, indirectness

The mean quality of life: SAQLI in the control groups was

4.6

The mean quality of life: comparison of values at endpoint - QOL: SAQLI - endpoint in the intervention groups was

0.5 higher

(0.09 lower to 1.09 higher)

Quality of Life: Comparison of Values at Endpoint - QoL: SF-36 (PH) – Endpoint

Scale from 0-100

Higher is better

334

(3 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, indirectness, imprecision

The mean quality of life: sf-36 (ph) - in the control groups was 46

The mean quality of life: comparison of values at endpoint - QOL: sf-36 (ph) - endpoint in the intervention groups was

1.09 higher

(0.34 lower to 2.52 higher)

Quality of Life: Comparison of Change from Baseline Values - QoL: FOSQ - Change from Baseline

Higher is better

(1 study)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, indirectness, imprecision

The mean quality of life: FOSQ - in the control groups was

1.1

The mean quality of life: comparison of change from baseline values - QOL: FOSQ - change from baseline in the intervention groups was

0.8 higher

(1.25 lower to 2.85 higher)

Quality of Life: Comparison of Change from Baseline Values - QoL: SF-36 (PH) - Change from Baseline

Higher is better

(1 study)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, indirectness, imprecision

The mean quality of life: sf-36 (ph) - in the control groups was 2.9

The mean quality of life: comparison of change from baseline values - QOL: sf-36 (ph) - change from baseline in the intervention groups was

0.3 higher

(3.1 lower to 3.7 higher)

Quality of Life: Comparison of Change from Baseline Values - QoL: FOSQ-10 - Change from Baseline

Higher is better

173

(1 study)

⊕⊝⊝⊝

VERY LOW¹^,²^,⁴

due to risk of bias, indirectness, imprecision

The mean quality of life: fosq-10 - in the control groups was

−14.2

The mean quality of life: comparison of change from baseline values - QOL: fosq-10 - change from baseline in the intervention groups was

3.3 higher

(0.1 to 6.5 higher)

diastolic blood pressure

(1 study)

⊕⊕⊕⊝

MODERATE²

due imprecision

The mean diastolic blood pressure in the control groups was 82.8

The mean diastolic blood pressure in the intervention groups was

4.4 lower

(9.82 lower to 1.02 higher)

systolic blood pressure

(1 study)

⊕⊕⊕⊝

MODERATE,²

due imprecision

The mean systolic blood pressure in the control groups was 138.8

The mean systolic blood pressure in the intervention groups was

9.3 lower

(17.57 to 1.03 lower)

AHI on treatment - Comparison of Values at Endpoint

Lower is better

411

(5 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,³

due to risk of bias, inconsistency, imprecision

The mean ahi on treatment performed in control group was

4.2

The mean ahi on treatment performed in the intervention groups was

0.80 higher

(0.66 lower to 2.25 higher)

Mortality (critical outcome)

Not reported

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by one increment if the confidence interval crossed one MID and downgraded by two increments if the confidence interval crossed both MIDs. MID for machine usage (adherence)- 1 hour; Established MIDs for SF-36 physical/mental- 2/3 ; FOSQ- 2 ; ESS −2.5;SAQLI – 2. GRADE default MID (0.5XSD) used for all other continuous outcomes.
3: Downgraded by 1 or 2 increments for heterogeneity,unexplained by subgroup analysis. Random effect analysis used.
4: Downgraded by 1 or 2 increments because the majority of the evidence included an indirect or very indirect population respectively
*: Not sleepy in both groups

Table 5Clinical evidence summary: Mixed (SUP/EDU/BEH) Intervention + CPAP versus Usual Care + CPAP - Severe OSAHS

Outcomes

No of Participants (studies) Follow up

Quality of the evidence (GRADE)

Relative effect (95 % CI)

Anticipated absolute effects

Risk with Control

Risk difference with Mixed (SUP/EDU/BEH) Intervention + CPAP versus Usual Care + CPAP (95% CI)

CPAP Device Usage (hours/night)

Higher is better

4451

(10 studies)

⊕⊝⊝⊝

VERY LOW¹^,²^,³^,⁴

due to risk of bias, inconsistency, imprecision, indirectness

The mean CPAP device usage (hours/night) in the control group was

4.8

The mean CPAP device usage (hours/night) in the intervention groups was

0.82 higher

(0.2 to 1.43 higher)

N deemed adherent (≥ four hours/night)

Higher is better

4015

(9 studies)

⊕⊝⊝⊝

VERY LOW¹^,³^,²^,⁴

due to risk of bias, inconsistency, imprecision indirectness

RR 1.14 (1.04 to 1.26)

Moderate

656 per 1000

92 more per 1000

(from 26 more to 171 more)

Withdrawal

4956

(11 studies)

⊕⊝⊝⊝

VERY LOW¹^,³^,²^,⁴

due to risk of bias, inconsistency, imprecision, indirectness

RR 0.64 (0.32 to 1.28)

Moderate

136 per 1000

49 fewer per 1000

(from 92 fewer to 38 more)

Quality of Life: Comparison of Change from Baseline Values - QoL: FOSQ-10 - Change from Baseline

Higher is better

176

(1 study)

⊕⊝⊝⊝

VERY LOW¹^,³^,⁴

due to risk of bias, indirectness, imprecision

The mean quality of life: fosq-10 - in the control groups was

−14.2

The mean quality of life: comparison of change from baseline values - QOL: FOSQ-10 - change from baseline in the intervention groups was

2.9 higher

(0.52 lower to 6.32 higher)

Quality of Life: Comparison of Change from Baseline Values - QoL: SF-36 (PH) - Change from Baseline

Higher is better

2836

(1 study)

⊕⊝⊝⊝

LOW¹^,⁴

due to risk of bias, indirectness

The mean quality of life: sf-36 (ph) - in the control groups was 5.9

The mean quality of life: comparison of change from baseline values - QOL: sf-36 (ph) - change from baseline in the intervention groups was

5.7 higher

(4.98 to 6.42 higher)

Quality of Life: Comparison of Values at Endpoint - QoL: FOSQ – Endpoint

Scale from 5-20

Higher is better

177

(1 study)

⊕⊝⊝⊝

LOW¹^,⁴

due to risk of bias, indirectness

The mean quality of life: FOSQ - in the control groups was

16.7

The mean quality of life: comparison of values at endpoint - QOL: FOSQ - endpoint in the intervention groups was

0.3 higher

(0.56 lower to 1.16 higher)

Quality of Life: Comparison of Values at Endpoint - QoL: SF-36 (PH) – Endpoint

Scale from 0-100

Higher is better

3014

(3 studies)

⊕⊝⊝⊝

LOW¹^,⁴

due to risk of bias, indirectness

The mean quality of life: sf-36 (ph) - in the control groups was 56.9

The mean quality of life: comparison of values at endpoint - QOL: sf-36 (ph) - endpoint in the intervention groups was

4.85 higher

(2.49 to 7.21 higher)

Epworth Sleepiness Scale Score

Scale from 0-24

Lower is better

6388

(8 studies)

⊕⊝⊝⊝

VERY LOW¹^,³^,⁴

due to risk of bias, imprecision, indirectness

The mean ESS in the control group was 8.4

The mean epworth sleepiness scale score in the intervention groups was

1.32 lower^*

(2.48 to 0.16 lower)

Mortality (critical outcome)

Not reported

1: Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias
2: Downgraded by 1 or 2 increments for heterogeneity,unexplained by subgroup analysis. Random effect analysis used.
3: Downgraded by one increment if the confidence interval crossed one MID and downgraded by two increments if the confidence interval crossed both MIDs. MID for machine usage (adherence)- 1 hour; Established MIDs for SF-36 physical/mental- 2/3 ; FOSQ- 2 ; ESS −2.5; SAQLI – 2.. GRADE default MID (0.5XSD) used for all other continuous outcomes.
4: Downgraded by 1 or 2 increments because the majority of the evidence included an indirect or very indirect population respectively
*: Not sleepy in both groups.

Final

Intervention evidence review

Developed by the National Guideline Centre, hosted by the Royal College of Physicians

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and, where appropriate, their carer or guardian.

Local commissioners and providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Bookshelf ID: NBK574320PMID: 34613679

Adherence

Authors

1. Adherence

1.1. Review question: What support improves adherence to CPAP or other interventions?

1.2. Introduction

1.3. PICO table

1.4. Clinical evidence

1.4.1. Included studies

OSAHS

CPAP

Oral devices

Positional modifiers

OHS

COPD-OSAHS overlap syndrome

1.4.2. Excluded studies

1.4.3. Summary of clinical studies included in the evidence review

1.4.4. Quality assessment of clinical studies included in the evidence review

1.5. Economic evidence

1.5.1. Included studies

1.5.2. Excluded studies

1.5.3. Health economic modelling

1.5.4. Health economic evidence statements

1.6. The committee’s discussion of the evidence

1.6.1. Interpreting the evidence

1.6.1.1. The outcomes that matter most

1.6.1.2. The quality of the evidence

OSAHS

CPAP

Positional modifiers

Oral devices

OHS

COPD-OSAHS overlap syndrome

1.6.1.3. Benefits and harms

OSAHS

CPAP

Behavioural therapy + CPAP versus control + CPAP

Educational interventions + CPAP versus usual care + CPAP

Increased practical support and encouragement during follow-up + CPAP versus usual care + CPAP

Mixed (educational/supportive/behavioural) intervention + CPAP versus usual care + CPAP

Interventions to improve adherence of interventions for OSAHS- committee’s consideration of the evidence

OHS

COPD-OSAHS overlap syndrome

1.6.2. Cost effectiveness and resource use

References

Appendices

Appendix A. Review protocols

Appendix B. Literature search strategies

Appendix C. Clinical evidence selection

Appendix D. Clinical evidence tables

Appendix E. Forest plots

Appendix F. GRADE tables

Appendix G. Health economic evidence selection

Appendix H. Excluded studies

H.1. Excluded clinical studies

H.2. Excluded health economic studies

Appendix I. Research recommendations

Tables

Table 1PICO characteristics of review question

Table 2Summary of studies included in the evidence review for CPAP

Table 3Clinical evidence summary: Behavioural therapy + CPAP versus control + CPAP- Severe OSAHS

Table 4Clinical evidence summary: Educational interventions + CPAP versus usual care + CPAP- Severe OSAHS

Table 5Clinical evidence summary: Increased practical support and encouragement during follow-up + CPAP versus usual care + CPAP - Severe OSAHS

Table 5Clinical evidence summary: Mixed (SUP/EDU/BEH) Intervention + CPAP versus Usual Care + CPAP - Severe OSAHS