RECRUITINGINTERVENTIONAL

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.

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.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - • Adults (aged ≥18 years old) referred with suspected Obstructive Sleep Apnoea - Patient has capacity to provide willing to sign a consent form - 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. Who Should NOT Join This Trial: - • 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 willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DIAGNOSTIC_TEST

WatchPAT 300

Participants will use the Sunrise diagnostic device simultaneously with their NHS sleep study - WatchPAT.

DIAGNOSTIC_TEST

Oximetry

Participants will use the Sunrise diagnostic device simultaneously with their NHS sleep study - oximetry.

DIAGNOSTIC_TEST

Sunrise

Patients will use the Sunrise device which is a submandibular wearable for overnight sleep studies

Locations (1)

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, South West, United Kingdom