Sunrise in Obstructive Sleep Apnoea study (SOSA). A comparison of the Sunrise mandibular movement monitoring device with overnight oximetry and WatchPAT in the diagnosis and management of obstructive sleep apnoea

Background

Obstructive Sleep Apnoea (OSA) is a common sleep-related breathing disorder associated with daytime tiredness, nocturnal sleep disturbance and impaired quality of life. Patient waiting lists for diagnostic sleep studies continue to increase nationally with services unable to meet demand. Current diagnostic testing includes respiratory polygraphy or oximetry, requiring manual interpretation contributing to pathway delays. The Sunrise wearable device uses mandibular movement (MM) and machine-learning to detect sleep and respiratory disturbance and is now recommended in NICE guidance for OSA screening. Evidence regarding Sunrise use in clinical services remains limited and there is no current published literature comparing to oximetry or WatchPAT 300.

Aim

To determine if implementing the Sunrise device into an adult OSA diagnostic pathway improves diagnostic efficiency and clinical decision making compared to current diagnostic testing including oximetry or WatchPAT 300.

Methods

This is a single centre, prospective study in the University Hospitals Bristol and Weston NHS Foundation Trust sleep unit. Adults referred with suspected OSA are triaged for standard testing – oximetry or WatchPAT 300 and simultaneously used the Sunrise test in their own homes. The oximetry and WatchPAT 300 results will be triaged as part of their NHS pathway. The Sunrise results will be triaged to produce a hypothetical management decision (CPAP initiation, further testing, clinical review or discharge), triagers will be blinded to the NHS study results. The primary outcome will be the proportion of patients where a management decision can be made based on Sunrise alone comparted with standard testing. Secondary outcomes include agreement in severity grading, compare sleep parameters, test failures, patient experience, clinician and patient feedback and staff time required to analyse each test.

Progress

Recruitment started in July 2025. Currently 99 patients out of a planned 120 have been recruited, dataset collection is ongoing and expected to finish November 2025. There have been higher failure rates than expected, initially due to patients having difficulty with the app. The dataset has not been analysed while recruitment is ongoing and there are no results to discuss. No adverse events or safety concerns have been identified to date.

Anticipated impact

If results demonstrate Sunrise diagnostic performance as comparable to WatchPAT and improved sensitivity over oximetry this could support reduced analysis time, reduced diagnostic pathways and reduced waiting list backlogs. Results will inform local pathway redesign and contribute to national guidance of wearable sleep diagnostic equipment.

Outputs

None to date