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 | Recruiting

• 1 other identifier: REC reference: 25/NW/0102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Obstructive Sleep Apnoea; Home-testing devices for Obstructive Sleep Apnoea; sleep-disordered breathing; Excessive daytime sleepiness; Sunrise device; WatchPAT 300; Overnight oximetry; wearable sleep diagnostic device; Home sleep study; mandibular movement monitoring; diagnostic accuracy study; single-centre study; digital health technology; patient experience; patient feedback; NHS innovation; waiting list reduction; machine learning in sleep medicine; Home-testing devices for diagnosing obstructive sleep apnoea hypopnoea syndrome NICE guidance 2024; diagnostic pathway efficiency; Obstructive Sleep Apnoea Hypopnoea syndrome; patient reported outcomes; cost effectiveness

Outcome Measures

Primary Outcomes (1)

• The proportion of patients for which a definitive management decision can be made when tested with Sunrise will be determined and compared to that of oximetry and WatchPAT 300.

  * The Principal Investigator (PI) will be blinded to the CRF after visit 1 to help ensure unbias analysis and triaging of Sunrise results. The database manager will complete the CRF after this point and update the study spreadsheet with the results. * Patients will return the Sunrise device the same time as their oximetry or WatchPAT 300. * Patient exits the study at this point. No further study requirements from the patient. * Sunrise results will be triaged by the PI and the clinical fellow. Both will be blinded to the oximetry and WatchPAT 300 triage outcome. * Hypothetical management plan following Sunrise Triage i) CPAP set up; ii) further diagnostic testing or iii) discharge from sleep service) iv) clinic appointment for further discussion. * The patient referral letter and new patient questionnaire will be consulted after Sunrise data hypothetical managements are determined, to compare the patient's clinical pathway following current practice and a CRF completed.

  • Patients recruited into the study will be issued the Sunrise device to use simultaneously for one night with oximetry or WatchPAT 300. • Patient exits the study when both devices are returned. • Sunrise results will be triaged by the PI and fellow

Study Arms (2)

WatchPAT 300

EXPERIMENTAL

WatchPAT 300 and Sunrise

Diagnostic Test: WatchPAT 300; Diagnostic Test: Sunrise

Oximetry

EXPERIMENTAL

Oximetry and Sunrise

Diagnostic Test: Oximetry; Diagnostic Test: Sunrise

Interventions

WatchPAT 300 DIAGNOSTIC_TEST

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

WatchPAT 300

Oximetry DIAGNOSTIC_TEST

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

Oximetry

Sunrise DIAGNOSTIC_TEST

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

Oximetry; WatchPAT 300

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Hawkins: lead
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator

Study Sites (1)

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, South West, Bs2 8HW, United Kingdom

RECRUITING

Related Publications (7)

• Moffa A, Giorgi L, Carnuccio L, Mangino C, Lugo R, Baptista P, Casale M. New diagnostic tools to screen and assess a still too underestimated disease: the role of the wrist-worn peripheral arterial tonometry device-a systematic review. Sleep Breath. 2023 Jun;27(3):817-828. doi: 10.1007/s11325-022-02700-4. Epub 2022 Aug 29.

  PMID: 36036338 BACKGROUND

• Martinot JB, Le-Dong NN, Cuthbert V, Denison S, Borel JC, Gozal D, Pepin JL. Respiratory Mandibular Movement Signals Reliably Identify Obstructive Hypopnea Events During Sleep. Front Neurol. 2019 Aug 13;10:828. doi: 10.3389/fneur.2019.00828. eCollection 2019.

  PMID: 31456731 BACKGROUND

• Martinot JB, Cuthbert V, Le-Dong NN, Coumans N, De Marneffe D, Letesson C, Pepin JL, Gozal D. Clinical validation of a mandibular movement signal based system for the diagnosis of pediatric sleep apnea. Pediatr Pulmonol. 2022 Aug;57(8):1904-1913. doi: 10.1002/ppul.25320. Epub 2021 Mar 1.

  PMID: 33647188 BACKGROUND

• Martinot JB, Borel JC, Cuthbert V, Guenard HJ, Denison S, Silkoff PE, Gozal D, Pepin JL. Mandibular position and movements: Suitability for diagnosis of sleep apnoea. Respirology. 2017 Apr;22(3):567-574. doi: 10.1111/resp.12929. Epub 2016 Nov 6.

  PMID: 28225162 BACKGROUND

• Martinot JB, Senny F, Denison S, Cuthbert V, Gueulette E, Guenard H, Pepin JL. Mandibular movements identify respiratory effort in pediatric obstructive sleep apnea. J Clin Sleep Med. 2015 Apr 15;11(5):567-74. doi: 10.5664/jcsm.4706.

  PMID: 25766710 BACKGROUND

• Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pepin JL. Diagnosis of Sleep Apnoea Using a Mandibular Monitor and Machine Learning Analysis: One-Night Agreement Compared to in-Home Polysomnography. Front Neurosci. 2022 Mar 15;16:726880. doi: 10.3389/fnins.2022.726880. eCollection 2022.

  PMID: 35368281 BACKGROUND

• Pepin JL, Letesson C, Le-Dong NN, Dedave A, Denison S, Cuthbert V, Martinot JB, Gozal D. Assessment of Mandibular Movement Monitoring With Machine Learning Analysis for the Diagnosis of Obstructive Sleep Apnea. JAMA Netw Open. 2020 Jan 3;3(1):e1919657. doi: 10.1001/jamanetworkopen.2019.19657.

  PMID: 31968116 BACKGROUND

Related Links

• Nice Guidelines: Home-testing devices for diagnosing obstructive sleep apnoea hypopnoea syndrome Diagnostics guidance Reference number:DG62 Published: 19 December 2024
• Nice Guidance: Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s (NICE guideline NG 202).
• Sunrise website

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Disorders of Excessive Somnolence

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Virginia Hawkins, BSc

  Manchester Metropolitan University

  STUDY CHAIR

Central Study Contacts

Rachel E Pickersgill, BSc

CONTACT

+44(0)117923 0000; rachel.pickersgill@uhbw.nhs.uk

Virginia Hawkins, PhD

CONTACT

+44(0)161 247 1092; v.hawkins@mmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * The Principal Investigator (PI) and Clinical fellow will be blinded to the CRF after visit 1 to help ensure unbias analysis and triaging of Sunrise results. The database manager will complete the CRF after this point and update the study spreadsheet with the results. * Sunrise results will be triaged by the PI and the clinical fellow. Both will be blinded to the oximetry and WatchPAT 300 triage outcome. * The unblinded investigators within UHBW will be the co-investigator and the trial database manager. * The PI and clinical fellow who will be triaging the Sunrise result will be blinded to the results of the WatchPAT 300 or oximetry result, and the clinical management decision made based on the WatchPAT 300 or oximetry result. Once data collection and triaging has finished, the oximetry and WatchPAT 300 result and the clinical management decision made on those results will be made available to the PI to analyse the study outcomes.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator - Senior Lecturer

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)