A Study Assessing Adult Patients Referred to an NHS Sleep Service With Suspected Obstructive Slee… (NCT07269483) | Clinical Trial Compass
RecruitingNot Applicable
A Study Assessing Adult Patients Referred to an NHS Sleep Service With Suspected Obstructive Sleep Apnoea. This Study Aims to Compare the Sunrise Wearable Diagnostic Device Performance and Potential Inclusion in a NHS Diagnostic Pathway With Oximetry and WatchPAT Which Are Currently Used.
United Kingdom100 participantsStarted 2025-07-28
Plain-language summary
The goal of this clinical trial is to evaluate whether the Sunrise device (that measure small jaw movements) can improve the diagnosis and management of Obstructive Sleep Apnoea (OSA) in adults (≥ 18 years) referred to a Sleep Clinic.
The main question it aims to answer are:
\- Does Sunrise lead to a higher proportion of definitive management decisions (initiate OSA treatment, discharge from the sleep clinic service, additional diagnostic testing required or a clinic appointment) compared to current screening practices, which includes either overnight oximetry or use of a wearable device called WatchPAT 300?
Researchers will compare Sunrise results with oximetry and WatchPAT 300 outcomes to see if Sunrise improves diagnostic efficiency, reduces time to a diagnosis or clinical decision and enhances patient experience.
Participants will:
* Follow the standard clinical pathway (oximetry or WatchPAT 300)
* Use the Sunrise device simultaneously for one night with their usual test
* Complete a patient feedback questionnaire on ease of use and experience
* Return all equipment two days later, Sunrise results will not affect their clinical care and will be used for the study only
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients for which a definitive management decision can be made when tested with Sunrise will be determined and compared to that of oximetry and WatchPAT 300.
Timeframe: • Patients recruited into the study will be issued the Sunrise device to use simultaneously for one night with oximetry or WatchPAT 300. • Patient exits the study when both devices are returned. • Sunrise results will be triaged by the PI and fellow