CES-EES score and a wearable ring for diagnosing obstructive sleep apnea
Official title: Validation of Clinical Upper Airway Assessment Tool With Artificial Intelligence Wearable Technology Against In-Lab Polysomnography
Run by University of Malaya · NCT07785999 · Data updated 2026-11-12
This study tests whether the CES-EES clinical score and the Belun Ring wearable can accurately diagnose obstructive sleep apnea without in-lab polysomnography in adults referred for suspected OSA.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Pantai Valley, Kuala Lumpur) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07785999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with suspected OSA and a CES-EES score of 4 or more, referred to an ENT sleep clinic, and able to complete a full-night assessment.
✕Probably not a fit
Patients with conditions or factors that prevent reliable wear of the ring or interpretation of the CES-EES score, or those whose OSA is not detectable by the wearable or score, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-centre study compares a clinical assessment tool (CES-EES) and a wearable AI ring (Belun Ring) against the standard in-lab polysomnography for diagnosing obstructive sleep apnea. Adults with suspected OSA and high sleep-symptom scores undergo a CES-EES assessment and wear the Belun Ring during a single overnight PSG, which serves as the reference standard. The study evaluates agreement, correlation, and diagnostic accuracy of the ring and the CES-EES, alone and in combination, relative to PSG outcomes. Eligibility includes adults 18+ with suspected OSA and CES-EES score of 4 or more, with adherence to predefined sleep-time criteria. The aim is to determine if these tools could offer a less resource-intensive diagnostic pathway for OSA.
Why it matters
Potential benefit: If successful, patients could receive accurate OSA screening and diagnosis with less need for in-lab testing, reducing cost and wait times.
How similar studies have gone: Prior tools and wearable sensors have shown variable and often limited agreement with PSG; this study builds on growing evidence but remains among early validations for combined clinical scores and wearables.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Universiti Malaya Medical Centre (UMMC)
Pantai Valley, Kuala Lumpur, Malaysia Recruiting
Study contacts
- Principal investigator: Varatha Raju Kugan, MD — Department of Otorhinolaryngology, Head & Neck Surgery, Universiti Malaya Medical Centre
- Study coordinator: Dr. Kugan a/l Varatha Raju, MD
- Email: kugan.varatha@ummc.edu.my
- Phone: +6012-4559957
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.