Authors' objectives: Obstructive sleep apnoea and hypopnea syndrome is a sleep-related breathing disorder. Diagnostic sleep studies for obstructive sleep apnoea and hypopnoea syndrome are conducted overnight in clinic using oximetry, respiratory polygraphy and polysomnography. Portable novel devices have been developed to facilitate home testing. To conduct: a systematic review of clinical effectiveness of novel home-testing devices in people with suspected obstructive sleep apnoea and hypopnoea syndrome a health economic evaluation modelling the incremental cost-effectiveness of novel home-testing devices compared to home respiratory polygraphy or oximetry. Obstructive sleep apnoea and hypopnoea syndrome (OSAHS) is a sleep-related breathing disorder in adults and children caused by intermittent narrowing or complete collapse of the upper airway, leading to episodes of reduced (hypopnoea) or absent (apnoea) airflow. Diagnostic tests for OSAHS are conducted overnight, either in the patient’s home, or a hospital sleep clinic. Current approaches are oximetry, respiratory polygraphy (RP) and polysomnography (PSG). Portable novel devices have been developed to facilitate home sleep studies. There is uncertainty over the clinical and cost-effectiveness of these novel devices. To conduct: a systematic review of the clinical effectiveness (including diagnostic performance) of novel home-testing devices in people with suspected OSAHS a health economic evaluation using decision-analytic modelling to assess the incremental cost-effectiveness of novel home-testing devices compared to home RP or home oximetry in people with suspected OSAHS systematic reviews of data parameters (e.g. costs and utilities) to inform the health economic evaluation.

Authors' results and conclusions: In adults, novel devices were compared to home respiratory polygraphy in four studies, to hospital sleep laboratory polysomnography in five studies, and home-based polysomnography in one study. No studies compared novel devices to home-based pulse oximetry. Sensitivity and specificity estimates vary between, and within, studies at different severity cut-offs. Sensitivity was generally high (between 80% and 100%), falling below 80% in just two studies. Specificity was more variable (between 25% and 100%), with many estimates in the 70–80% range. Some estimates were uncertain, and we caution making inferences about relative differences between novel devices. The percentage of test failures ranged from 0% to 18%. Limited data were available on many other outcomes. Only three studies included children, and all of these were done in the clinic rather than the home setting. In the base-case economic analysis, all six novel devices are less costly than respiratory polygraphy and slightly less effective. For the AcuPebble and Sunrise (Sunrise) devices, the reduction in quality-adjusted life-years was cost-effective compared to the reduction in costs (i.e. incremental net monetary benefit > £0 at the £20,000 and £30,000 per quality-adjusted life-year thresholds). All six novel devices are more costly and more effective than oximetry, with incremental costs below £10,000 per quality-adjusted life-year gained. Additional analyses highlight the extent of uncertainty. Novel devices for home-based sleep studies in adults are a cost-effective alternative to oximetry, albeit with some uncertainty. It is difficult to assess the cost-effectiveness of the novel devices compared with respiratory polygraphy. Systematic review of diagnostic test evaluation and clinical effectiveness The combined May 2023 and September 2023 searches of literature and other sources identified a total of 290 references subjected to full-text screening; 239 were excluded, mostly for reporting an intervention not relevant to the scope. A further 21 references did not report sufficient information to inform a screening decision. The remaining 30 publications reported a total 18 studies meeting the inclusion criteria for this systematic review. Of the 18 studies: 14 are included adults, and 3 studies included children. One study met our inclusion criteria but did not report any results. Implications for service provision Based on the clinical reviews and economic evaluation, we suggest the following conclusions related to services for people aged over 16 years undergoing home-based testing for suspected OSAHS: The estimated cost of the diagnostic pathway is lowest for oximetry and highest for RP, with the cost for the novel devices lying in between. This is also true for total costs, including costs of OSAHS treatment (if indicated) and costs for care and treatment after CV events and RTAs, in addition to costs for diagnosis. Estimated total costs are similar for the six novel devices, and differences between these cost estimates are highly uncertain. Although oximetry has the lowest cost of the included devices, it has relatively poor sensitivity. In particular, oximetry is estimated to misclassify a high proportion of people with mild OSAHS as not having OSAHS, and a high proportion of people with moderate or severe OSAHS as having mild OSAHS. This implies that patients who would benefit from treatment are not treated or that their treatment may be delayed. All of the novel devices therefore appear to offer relatively good value for money when compared against oximetry; however, given the studies informing the performance of oximetry were published over 15 years ago, there is still uncertainty in these conclusions. All novel devices are estimated to have lower total costs and to produce fewer QALYs than RP, but these differences are very small and highly uncertain. We emphasise that there is high uncertainty over the relative diagnostic accuracy estimates for all devices and advise caution in interpreting these results.

Authors' methods: A systematic review of clinical effectiveness was conducted based on a predefined protocol. Searches were conducted between 22 May 2023 and 24 May 2023 and were updated on 25 September 2023. Screening, data extraction and critical appraisal were conducted by two reviewers. To be included, studies (of any design) had to evaluate one or more of six novel home device products used in adults and/or children with suspected obstructive sleep apnoea and hypopnoea syndrome. A structured descriptive synthesis was done. We reviewed health economic studies and developed a model to assess cost-effectiveness. There is uncertainty in the diagnostic test accuracy data comparing the novel devices with respiratory polygraphy, but less uncertainty compared to oximetry. For both comparators, data from a clinic, rather than home test setting are used, and some outcomes have not been modelled. There is insufficient evidence to assess the cost-effectiveness of novel home devices in children. Systematic review of clinical effectiveness The proposed methods for the systematic review of clinical effectiveness were predefined in a published protocol (PROSPERO registration number CRD42023443437). The final protocol was published on the National Institute for Health and Care Excellence (NICE) website in June 2023. The search strategy was applied to a range of relevant health and medical research databases and trial registers, including MEDLINE, EMBASE and the Cochrane Library. Searching was done between 22 and 24 May 2023 and was repeated on 25 September 2023. No date limits were applied. Predefined inclusion and exclusion criteria (based on the decision problem defined in the NICE scope) were: studies of six novel home testing device products used in adults and/or children with suspected OSAHS. Screening of titles and abstracts was conducted by two reviewers independently, and disagreements were resolved by discussion. One reviewer screened the full texts of references judged potentially relevant, and a second reviewer checked the first reviewer’s judgement. Any discrepancies were resolved through discussion. Where study eligibility remained unclear, we contacted the authors and requested further information. Relevant data were extracted from each included study: study design and methods, characteristics of the study population, intervention and comparator(s), and study outcomes. A single reviewer extracted data, which were checked by a second reviewer and any discrepancies were resolved. Included studies were critically appraised for risk of bias and applicability using the quality assessment of diagnostic accuracy studies-2 instrument. Each study was appraised by one reviewer and checked by a second, with any disagreements resolved through discussion. The extracted data were included in a structured descriptive synthesis of clinical effectiveness. The synthesis presents a tabulated summary of numerical and statistical data, with accompanying textual description. We considered that clinical heterogeneity was substantial and that meta-analysis would therefore be inappropriate. The cost-effectiveness analysis is limited by the availability and quality of data for many of the model components, including limited accuracy data in the home and the effects of post hoc optimisation of thresholds for sensitivity and specificity. Our analysis does not capture the potential for greater patient acceptability of home-based testing with novel devices over the comparators, neither does it include the impact of comorbidities. A key limitation is that our economic model is only relevant to people over the age of 16 years and that we have not been able to conduct subgroup analysis to investigate potential equality issues: for example, related to concerns over the sensitivity of oximetry and other light-based assessment methods for people with darker skin tones.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR135895

Year Published: 2026

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/GJJS3014

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/GJJS3014

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk