Comparing the Sunrise jaw‑movement wearable with oximetry and WatchPAT for diagnosing obstructive sleep apnoea
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.
This will test whether the Sunrise jaw‑movement wearable can help diagnose obstructive sleep apnoea in adults referred to an NHS sleep clinic by comparing it with overnight oximetry or the WatchPAT device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Manchester Metropolitan University Academic / other |
| Locations | 1 site (Bristol, South West) |
| Trial ID | NCT07269483 on ClinicalTrials.gov |
What this trial studies
Adults referred with suspected obstructive sleep apnoea will use the Sunrise jaw‑movement wearable at home for one night at the same time as their usual diagnostic test (overnight oximetry or WatchPAT 300). Researchers will compare how often the different tests lead to a definitive management decision (start treatment, discharge, need more testing, or schedule a clinic appointment), plus time to decision and patient experience. The device has prior validation against full polysomnography with reported high accuracy, and this study embeds the device into an existing NHS diagnostic pathway to test real‑world performance. The study also seeks to include patients of diverse ethnic backgrounds to address gaps noted in guidance about device accuracy across skin tones.
Who should consider this trial
Good fit: Adults (≥18 years) referred with suspected obstructive sleep apnoea who can give informed consent, have a smartphone with Bluetooth/WiFi to run the Sunrise app, and can follow English or picture‑guided instructions are eligible.
Not a fit: Patients with suspected non‑OSA sleep disorders, chronic hypercapnic respiratory failure, unstable cardiovascular disease, non‑arteritic anterior ischaemic optic neuropathy, or those without smartphone/internet access are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, Sunrise could speed up and simplify home testing for OSA, leading to faster treatment decisions and a better patient experience.
How similar studies have performed: Previous validation studies comparing Sunrise to full polysomnography reported around 88–100% accuracy depending on severity and a 92% accuracy in one comparison, so the device has supportive evidence though pathway integration is less studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Adults (aged ≥18 years old) referred with suspected Obstructive Sleep Apnoea * Patient has capacity to provide informed consent * Patient has access to a smartphone with Bluetooth and WiFi or internet data to download the Sunrise app and to transmit the Sunrise results to the Sunrise portal. UHBW Trust Wi-Fi available to the patient at equipment collection and return if needed. * Willing and able to comply with the study-specific procedures * Ability to read and comprehend English or understand simple device user instructions with guided pictures in English. Exclusion Criteria: * • Suspected diagnosis of a sleep disorder other than OSA (including central sleep apnoea, parasomnias, narcolepsy, idiopathic hypersomnia) * Suspected chronic hypercapnic respiratory failure (history of acute hypercapnic respiratory failure, raised CO2 or serum bicarbonate) * Patients with unstable cardiovascular disease or non-arteritic anterior ischaemic optic neuropathy * Patients with beards who are unwilling to shave the area below their lip (the soul patch) * Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint * Unable to consent or lacks capacity to provide informed consent * In-patient referrals * Unwilling or unable to comply with the study-specific procedures. * Patients who have requested in their medical notes not to be involved in research or not to receive digital communication
Where this trial is running
Bristol, South West
- University Hospitals Bristol and Weston NHS Foundation Trust — Bristol, South West, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rachel E Pickersgill, BSc
- Email: rachel.pickersgill@uhbw.nhs.uk
- Phone: +44(0)117923 0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.