Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07269483

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.

Led by Virginia Hawkins · Updated on 2025-12-19

100

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

Sponsors

V

Virginia Hawkins

Lead Sponsor

U

University Hospitals Bristol and Weston NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older referred with suspected Obstructive Sleep Apnoea
  • Ability to provide informed consent
  • Access to a smartphone with Bluetooth and WiFi or internet data to use the Sunrise app
  • Willing and able to follow study procedures
  • Ability to read and understand English or follow simple English instructions with pictures
Not Eligible

You will not qualify if you...

  • Suspected sleep disorders other than Obstructive Sleep Apnoea (including central sleep apnoea, parasomnias, narcolepsy, idiopathic hypersomnia)
  • Suspected chronic hypercapnic respiratory failure
  • Unstable cardiovascular disease or non-arteritic anterior ischaemic optic neuropathy
  • Beard and unwillingness to shave the area below the lip
  • Conditions affecting jaw joint rotation
  • Unable to consent or lacks capacity
  • In-patient referrals
  • Unwilling or unable to comply with study procedures
  • Patients who have requested not to be involved in research or to avoid digital communication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, South West, United Kingdom, Bs2 8HW

Actively Recruiting

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Research Team

R

Rachel E Pickersgill, BSc

CONTACT

V

Virginia Hawkins, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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