Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, South West, United Kingdom, Bs2 8HW
Actively Recruiting
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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