Comparing the Sunrise jaw‑movement wearable with oximetry and WatchPAT for diagnosing obstructive sleep apnoea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.