| Study | Intervention and comparison | Population | Outcomes | Comments |
|---|---|---|---|---|
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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:
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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. |
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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. |
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Included in Cochrane review Behavioural vs control Severe OSAHS based on mean AHI |
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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:
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. |
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 |
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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. |
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Included in Cochrane review Moderate OSAHS based on mean AHI |
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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 |
| Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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 |
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Included in Cochrane review Unpublished information on study design and outcomes obtained from study authors Severe OSAHS based on mean AHI |
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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 15th and 30th 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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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) |
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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 |
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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. |
| Moderate and severe OSAHS |
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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 |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Only CPAP and CPAP + Myofunctional therapy groups included in Review/meta-analysis. |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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 |
| Severe OSAHS based on mean AHI. |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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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 |
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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 90th percentile of pressure was >16 com H20 or mask leakage of the 95th 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) |
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Follow-up 12 months Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Moderate OSAHS based on mean AHI |
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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. |
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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 |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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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 |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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) |
| Severe OSAHS based on mean AHI |
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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) |
| Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean RDI |
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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. |
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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 |
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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. |
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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 |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean RDI. |
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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. |
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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 |
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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. |
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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 |
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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. |
| Severe OSAHS based on mean AHI |
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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. |
| Included in Cochrane review |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Moderate OSAHS based on mean AHI |
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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. |
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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. |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
| Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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. |
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Included in Cochrane review Severe OSAHS based on mean AHI |
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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). |
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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 |
From: Adherence
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