CES-EES Clinical Score and a Wearable Ring Sensor for Obstructive Sleep Apnea: Individual and Combined Validation Against In-Laboratory Polysomnography
Key facts
- Who runs it
- University of Malaya
- Where
- Pantai Valley, MalaysiaSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 58 people, planned
- Started
- 1 Mar 2026
- Expected to end
- 1 Mar 2027
- Type of study
- Observational
- Treatments tested
- Belun Ring (Belun Sleep System BLS-100)
- CES-EES Clinical Scoring
- Record updated
- 25 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- ≥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)
Who cannot take part
- Alcohol consumption within 8 hours prior to testing
- Active psychiatric disorders and currently on psychiatric medication
- Active URTI (upper respiratory tract infection) in the past 1 month
- History of head and neck carcinoma
- Active respiratory or neurological disorders
- Current smoker
Where in Malaysia
- Universiti Malaya Medical Centre (UMMC)Pantai Valley, MalaysiaContact: Varatha Raju Kugan, MD (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab P
Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab PSG
Treatment: Belun Ring (Belun Sleep System BLS-100) and CES-EES Clinical Scoring
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Validation of Clinical Upper Airway Assessment Tool With Artificial Intelligence Wearable Technology Against In-Lab Polysomnography
- Record updated
- 25 August 2026