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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.

RecruitingNAAges 18 Years - anyAllVirginia Hawkins
NCT07269483 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 (oximetr

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📋 Eligibility rules (as published)
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
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What it tests

  • WatchPAT 300
  • Oximetry
  • Sunrise
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Where

1 site
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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