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

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.

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.

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.

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.

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.

More research is needed on the effectiveness of novel test devices used at home rather in clinics, trial-based designs and studies in children.

This study is registered as PROSPERO CRD42023443437.

This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135895) and is published in full in Health Technology Assessment; Vol. 30, No. 65. See the NIHR Funding and Awards website for further award information.