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RECRUITING
NCT07269483
NA

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.

Sponsor: Virginia Hawkins

View on ClinicalTrials.gov

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

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-07-28

Completion Date

2026-09-30

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

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