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Positional modifiers

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

Evidence review H

NICE Guideline, No. 202

.

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4229-9

1. Positional modifiers

1.1. Review question: What is the clinical and cost effectiveness of interventions to modify sleeping position for people with obstructive sleep apnoea hypopnoea syndrome (OSAHS)?

1.2. Introduction

Sleep disordered breathing is often worse when people are supine. Positional modifiers can potentially benefit those patients with positional sleep apnoea which, in its simplest definition, is OSAHS where a person has at least twice as many breathing events when supine compared to when non-supine. Broadly the interventions can be divided into two main categories: a physical barrier to supine sleep, and newer technologies involving sleep position training through a vibratory stimulus to discourage supine sleep.

A variety of techniques have been tried over many years, but results have varied, and this has not led to a standardised practice. New devices have been marketed recently, some of which are undergoing evaluation via research trials. There are cost implications of these devices and hence robust evidence regarding cost and efficacy is required to guide practice.

1.3. PICO table

For full details see the review protocol in appendix A.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

1.4. Clinical evidence

1.4.1. Included studies

Seven studies (8 papers) comparing positional modifiers with oral devices, CPAP or no active treatment were included in the review;2, 3, 5, 6, 11, 13, 15, 26 these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).

Two studies compared physical positional modifiers with no active treatment in moderate OSAHS population. One study had two comparisons: one compared electronic positional modifiers with no active treatment, and another compared electronic positional modifiers with oral devices (tongue retaining devices) in severe OSAHS population. One study compared electronic positional modifiers with custom made oral devices in mild OSAHS population. Three studies compared physical positional modifiers with CPAP in moderate OSAHS population.

The positional modifiers in the studies included physical devices with a tennis ball in a sling on the back or an electronic sleep position trainer. There was no evidence for other types of positional modifiers.

Studies were stratified based on the AHI of the population. When a mixed severity population was included, the severity of the majority of the population was used by taking the mean AHI of the patients included and the study was downgraded for indirectness.

Follow-up in the studies ranged from 1 to 3 months.

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 H.

1.4.2. Excluded studies

See the excluded studies list in appendix I.

1.4.3. Summary of clinical studies included in the evidence review

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of 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

Table 3. Clinical evidence summary: Positional modifiers vs no active treatment - moderate OSAHS.

Table 3

Clinical evidence summary: Positional modifiers vs no active treatment - moderate OSAHS.

Table 4. Clinical evidence summary: Positional modifiers vs no active treatment - severe OSAHS.

Table 4

Clinical evidence summary: Positional modifiers vs no active treatment - severe OSAHS.

Table 5. Clinical evidence summary: Positional modifiers vs oral devices - mild OSAHS.

Table 5

Clinical evidence summary: Positional modifiers vs oral devices - mild OSAHS.

Table 6. Clinical evidence summary: Positional modifiers vs oral devices - severe OSAHS.

Table 6

Clinical evidence summary: Positional modifiers vs oral devices - severe OSAHS.

Table 7. Clinical evidence summary: Positional modifiers vs CPAP - moderate OSAHS.

Table 7

Clinical evidence summary: Positional modifiers vs CPAP - moderate OSAHS.

See appendix F for full GRADE tables.

1.5. Economic evidence

1.5.1. Included studies

No relevant health economic studies were identified.

1.5.2. Excluded studies

No health economic studies that were relevant to this question 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

This area was not prioritised for new cost-effectiveness analysis.

1.5.4. Unit costs

Table 8. UK costs of Positional Modifiers.

Table 8

UK costs of Positional Modifiers.

1.5.5. 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 health-related quality of life and mortality as critical outcomes for decision making. Other important outcomes included sleepiness scores, Apnoea–Hypopnoea Index (AHI) or respiratory disturbance index, supine AHI, oxygen desaturation index (ODI), treatment success (reduction in supine sleeping), minor adverse effects of treatment, adherence, driving outcomes, neurocognitive outcomes, patient preference, impact on co-existing conditions such as HbA1c for diabetes, cardiovascular events for cardiovascular disease and systolic blood pressure for hypertension.

There was no evidence available for driving outcomes, neurocognitive outcomes, patient preference, or the impact on co-existing conditions.

1.6.1.2. The quality of the evidence

There was limited evidence, taken from seven small studies: one study compared an electronic positional modifier with oral devices (custom made titratable device), two studies compared physical positional modifiers with no active treatment, three studies compared physical positional modifiers with CPAP, and one study compared physical positional modifiers with oral devices (tongue retaining device) and with no active treatment. Follow-up in the studies ranged from 1 to 3 months.

The physical positional modifiers in the included studies were the tennis ball technique, where a tennis ball is attached to the person’s back in a sling, and an electronic sleep position trainers. Importantly there was no evidence for other types of physical positional devices, such as lumbar or abdominal binders, semi-rigid backpacks and full length pillows.

Severity of OSAHS in the populations in the included studies ranged from mild to severe.

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.

The quality of the evidence varied from moderate to very low quality. The majority of the evidence was downgraded due to risk of bias, imprecision and indirectness. Risk of bias was most commonly due to selection bias and lack of blinding. Subjective outcomes such as: ESS, FOSQ and SF36 physical and mental components were downgraded differently compared to objective outcomes such as AHI, AHI supine, % of total sleep time, systolic blood pressure, ODI, change in supine sleep percentage. The committee agreed that subjective and objective outcomes would be affected differently by selection bias and/or blinding. 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. When a mixed severity population was included (i.e. mild and moderate severity OSAHS), the severity of the majority of the population was determined by the mean value and the study was downgraded for indirectness. The committee took into account the quality of the evidence, including the uncertainty in their interpretation of the evidence.

1.6.1.3. Benefits and harms
Mild OSAHS - Positional modifiers vs oral devices

The evidence suggested that there was a clinically important benefit of positional modifiers compared to oral devices for the outcomes of minor adverse events and change in supine sleep position, with uncertainty around the results. The evidence suggested that there was no clinically important difference between positional modifiers and oral devices for the following outcomes: quality of life (FOSQ), symptoms (ESS), AHI, supine AHI, ODI and adherence. The committee therefore did not feel there was sufficient evidence to support their use over oral devices.

Moderate OSAHS - Positional modifiers vs no active treatment

The evidence suggested that there was a clinically important benefit of positional modifiers compared to no active treatment for the outcomes of AHI, supine AHI (BMI of less than 30 kg/m2), percentage of total sleep time spent in supine position and systolic BP. However, there was uncertainty around the evidence for outcomes of AHI, supine AHI (BMI of less than 30 kg/m2), and systolic BP. The evidence suggested that there was no clinically important difference between positional modifiers and no active treatment for: supine AHI (BMI of 30 kg/m2 or more), FOSQ and ESS. The committee also noted that some of the outcomes such as FOSQ, supine AHI (BMI of 30 kg/m2 or more) and systolic blood pressure included obese people (BMI of 30 kg/m2 or more) only. For other outcomes such as ESS, AHI, and % of total sleep time spent in supine position the population was mixed in terms of obesity including patients with BMI both above and below 30.

The committee agreed that the ability of positional modifiers to lower AHI and avoid supine sleep in this population was promising, although they noted the lack of symptomatic benefit experienced by the patients, which likely relates to the short follow up period and low numbers completing the trial. More research is needed in this area, and the committee were aware of ongoing RCTs which may offer further insight.

Moderate OSAHS - Positional modifiers vs CPAP

The evidence suggested that there was a clinically important benefit of positional modifiers compared to CPAP for the outcomes of supine sleeping percentage, total supine sleeping time and adherence (self-reported compliance and percentage of nights with ≥4 hours use), with uncertainty around evidence for supine AHI and adherence (percentage of nights with ≥4 hours use). However, the evidence suggested that there was clinically important benefit of CPAP compared to positional modifiers for the outcomes of AHI (total and supine), , and preference, with uncertainty around the evidence for AHI (total and supine) and preference. This may explain why there was no clinically important difference between positional modifiers and CPAP for quality of life (FOSQ, SF-36), ODI, symptoms (ESS),despite better adherence with the positional modifier. There was also no clinically important difference between positional modifiers and CPAP for the outcome of adverse events. Interestingly, even though compliance was better when considered against CPAP there was still no symptomatic benefit, probably as a result of greater AHI control in the CPAP patients.

Severe OSAHS - Positional modifiers vs no active treatment

The evidence suggested that there was a clinically important worsening with positional modifiers compared to no treatment for the outcome AHI, with uncertainty around the evidence. This finding fitted with the committee’s clinical experience that in the severe OSAHS population, multiple sleep disordered breathing events occur in both the supine and the non-supine position so the avoidance of supine sleep would be insufficient to reverse the OSAHS. The evidence suggested that there was no clinically important difference between positional modifiers and no active treatment for the outcome supine AHI.

Severe OSAHS - Positional modifiers vs oral devices

The evidence suggested that there was a clinically important benefit of oral devices compared to positional modifiers for the outcome AHI, although there was some uncertainty around the effect estimate. The evidence suggested that there was no clinically important difference between positional modifiers and oral devices for the outcome supine AHI.

Positional modifiers for OSAHS- committee’s consideration of the evidence

Because there was limited evidence on positional modifiers to treat OSAHS and the available studies were small with limited follow-up, the guideline committee used its knowledge and experience to make recommendations.

In summary, the committee agreed that positional modifiers were effective in reducing time spent sleeping in the supine position without a detrimental effect on sleep quality, with no evidence of adverse effects. They noted that positional modifiers were not as effective at reducing AHI as CPAP, despite better adherence to therapy. The committee agreed that the evidence did not support their use as a first-choice treatment over CPAP or mandibular advancement splints in patients with mild or moderate positional OSAHS. However, there was some evidence of a reduction of OSAHS severity in supine sleep and an associated fall in the number of apnoeas compared to no treatment, with no evidence of adverse effects, so the committee agreed that they could be an option if other treatments were unsuccessful or not tolerated. It is estimated that more than half of people with OSAHS have positional OSAHS, so this recommendation will give more choice and offer an alternative option for those who find CPAP and oral devices/mandibular advancement splints difficult to tolerate or unsuitable. Self-reported adherence with positional devices is favourable. The committee drafted recommendations to reflect this.

The committee did not support the use of position modifiers in the severe population, since people with severe OSAHS tend to have obstructive events whichever position they are lying in. The committee was also aware of evidence that suggested an increase in the number of apnoeas with the use of positional modifiers in this population. With this in mind the committee made a be aware recommendation that positional modifiers are unlikely to be effective in severe OSAHS.

The studies looked at a variety of different positional modifiers, including the tennis ball technique and an electronic sleep position trainer, but the committee noted that that they did not include other devices such as lumbar or abdominal binders, semi-rigid backpacks and full-length pillows. The evidence base is also limited with no long term follow up periods. All the studies were of short duration; hence it is not clear about the long-term effects of these interventions. This is important, as most of the quality of life outcomes will be evident only when the therapies are given over a longer period of time. The committee agreed that the evidence for different types of positional modifiers was insufficient to recommend a specific device.

The committee acknowledged that several randomised control trials including the POSA trial (Positional Therapy for Obstructive Sleep Apnoea: a Randomised Controlled Trial to assess the effect on Health and Wellbeing in Older and Younger People) were in progress that may shed some light on this area in due course and therefore they did not feel a research recommendation was necessary.

Positional modifiers are not used commonly in current practice hence implementing these recommendations would require a change in practice by most providers. Currently people tend to buy their own positional devices, often after not tolerating CPAP or mandibular advancement splints. However, it is only an option if CPAP and mandibular advancement splints are unsuccessful so increased uptake of these devices and resource impact is likely to be small.

1.6.2. Cost effectiveness and resource use

In the absence of clear clinical evidence, and no economic evaluations, the committee made a consensus recommendation based on their expertise.

The committee limited their recommendation to people with positional OSAHS only. Using these devices in the absence of positional OSAHS could render the device clinically ineffective and would not be a cost-effective use of resources.

The yearly cost of supplying and monitoring a positional modifier was substantially less than the cost of continuous positive airway pressure devices (see Evidence reports E and F). The committee therefore noted there was a potential for cost savings for the NHS if some people can be treated effectively with positional modifiers.

In summary, the committee are of the view that positional modifiers could be a cost-effective use of resources if limited to people with positional OSAHS only. While these devices are currently not used in practice, their use could result in cost-savings as they are a less expensive alternative to CPAP over a lifetime horizon.

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Appendices

Appendix B. Literature search strategies

Sleep Apnoea search strategy 9 position modification

This literature search strategy was used for the following review;

  • What is the clinical and cost effectiveness of interventions to modify sleeping position for people with obstructive sleep apnoea/hypopnoea syndrome?

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.16

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, 311K)

B.2. Health Economics literature search strategy (PDF, 346K)

Appendix D. Clinical evidence tables

Download PDF (282K)

Appendix G. Health economic evidence selection

Figure 35. Flow chart of health economic study selection for the guideline (PDF, 226K)

Appendix H. Excluded studies

H.1. Excluded clinical studies

Download PDF (129K)

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.

This appendix is not available from the publisher at this time.

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.

Copyright © NICE 2021.
Bookshelf ID: NBK574327PMID: 34613672

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