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Taking people in MalaysiaNo phase

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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