Home-testing devices for diagnosing obstructive sleep apnoea hypopnoea syndrome: a systematic review and economic evaluation

Background: Obstructive sleep apnoea and hypopnoea syndrome (OSAHS) is a sleep-related breathing disorder. Diagnostic sleep studies for OSAHS are conducted overnight in clinic using oximetry, respiratory polygraphy (RP) and polysomnography (PSG). Portable novel devices have been developed to facilitate home testing. <br/>Objectives: To conduct: • a systematic review of clinical effectiveness (including diagnostic performance) of novel home-testing devices in people with suspected OSAHS. • a health economic evaluation modelling the incremental cost-effectiveness of novel home-testing devices compared to home RP or oximetry.<br/>Data sources and methods: A systematic review of clinical effectiveness was conducted based on a pre-defined protocol. Searches were conducted between 22nd - 24th May 2023, and updated on 25th September 2023. Screening, data extraction and critical appraisal was 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 OSAHS. A structured descriptive synthesis was done. We reviewed health economic studies and developed a model to assess cost-effectiveness.<br/>Results: In adults, novel devices were compared to home RP in four studies, to hospital sleep-laboratory PSG in five studies, and home-based PSG 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% to 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. <br/>In the base case economic analysis, all six novel devices are less costly than RP, and slightly less effective. For the AcuPebble and Sunrise devices, the reduction in quality-adjusted life-years (QALYs) may be cost-effective compared to the reduction in costs (i.e. Incremental net monetary benefit (INMB) &gt; £0 at the £20,000 and £30,000 per QALY thresholds). All six novel devices are more costly and more effective than oximetry, with incremental costs below £10,000 per QALY gained. Additional analyses highlight the extent of uncertainty.<br/>Limitations: There is uncertainty in the diagnostic test accuracy data comparing the novel devices with RP, 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.<br/>Conclusions: 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 RP.<br/>Future work: More research is needed on: the effectiveness of novel test devices used at home rather in clinics; trial-based designs; studies in children.<br/>