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
• 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
• 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)
Parallel
WatchPAT 300
Diagnostic testParticipants will use the Sunrise diagnostic device simultaneously with their NHS sleep study - WatchPAT.
Oximetry
Diagnostic testParticipants will use the Sunrise diagnostic device simultaneously with their NHS sleep study - oximetry.
Sunrise
Diagnostic testPatients will use the Sunrise device which is a submandibular wearable for overnight sleep studies
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.
* The Principal Investigator (PI) will be blinded to the CRF after visit 1 to help ensure unbias analysis and triaging of Sunrise results. The database manager will complete the CRF after this point and update the study spreadsheet with the results. * Patients will return the Sunrise device the same time as their oximetry or WatchPAT 300. * Patient exits the study at this point. No further study requirements from the patient. * Sunrise results will be triaged by the PI and the clinical fellow. Both will be blinded to the oximetry and WatchPAT 300 triage outcome. * Hypothetical management plan following Sunrise Triage i) CPAP set up; ii) further diagnostic testing or iii) discharge from sleep service) iv) clinic appointment for further discussion. * The patient referral letter and new patient questionnaire will be consulted after Sunrise data hypothetical managements are determined, to compare the patient's clinical pathway following current practice and a CRF completed.
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Virginia Hawkins
Lead sponsor
Manchester Metropolitan University
Sponsor institution
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborator
