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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.

NCT07269483 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-19

No results posted yet for this study

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

Conditions

  • Obstructive Sleep Apnoea (OSA)

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

Sponsors & Collaborators

  • University Hospitals Bristol and Weston NHS Foundation Trust

    collaborator OTHER

  • Virginia Hawkins

    lead OTHER

Principal Investigators

  • Virginia Hawkins, BSc · Manchester Metropolitan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269483 on ClinicalTrials.gov