NCT07785999 CES-EES Clinical Score and a Wearable Ring Sensor for Obstructive Sleep Apnea: Individual and Combined Validation Against In-Laboratory Polysomnography
| NCT ID | NCT07785999 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Malaya |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 58 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 58 participants in total. It began in 2026-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates whether a clinical upper airway assessment tool (the Clinical Examination Score plus ENT Examination Score, CES-EES) and an artificial-intelligence wearable ring (Belun Ring, Belun Sleep System BLS-100) can serve as accurate, less resource-intensive alternatives to in-lab polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA). Adults referred to the Otorhinolaryngology sleep clinic at Universiti Malaya Medical Centre (UMMC) for suspected OSA, who score 4 or more on the combined CES-EES scale, undergo a single overnight Level 1 in-lab PSG. The Belun Ring is worn concurrently with standard PSG electrodes during this same overnight study. The apnea-hypopnea index (AHI) from the Belun Ring and the CES-EES score, individually and in combination, are compared against the AHI from in-lab PSG -- the diagnostic reference standard -- to assess their agreement, correlation, and diagnostic accuracy for OSA.
Eligibility Criteria
Inclusion Criteria: * ≥18 years old * Patients with suspected OSA (high ESS and/or STOP-BANG score) * CES-EES score 4 or more * Newly diagnosed cases * Minimum 4 hours of Total Sleep Time (TST) Exclusion Criteria: * Active URTI (upper respiratory tract infection) in the past 1 month * Current smoker * Alcohol consumption within 8 hours prior to testing * History of head and neck carcinoma * Active respiratory or neurological disorders * Active psychiatric disorders and currently on psychiatric medication
Contact & Investigator
Varatha Raju Kugan, MD
PRINCIPAL INVESTIGATOR
Department of Otorhinolaryngology, Head & Neck Surgery, Universiti Malaya Medical Centre
Frequently Asked Questions
Who can join the NCT07785999 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07785999 currently recruiting?
Yes, NCT07785999 is actively recruiting participants. Contact the research team at kugan.varatha@ummc.edu.my for enrollment information.
Where is the NCT07785999 trial being conducted?
This trial is being conducted at Pantai Valley, Malaysia.
Who is sponsoring the NCT07785999 clinical trial?
NCT07785999 is sponsored by University of Malaya. The principal investigator is Varatha Raju Kugan, MD at Department of Otorhinolaryngology, Head & Neck Surgery, Universiti Malaya Medical Centre. The trial plans to enroll 58 participants.