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CES-EES Clinical Score and a Wearable Ring Sensor for Obstructive Sleep Apnea: Individual and Combined Validation Against In-Laboratory Polysomnography

NCT07785999 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Belun Ring (Belun Sleep System BLS-100)

AI/deep-learning-facilitated wearable ring worn on the index finger concurrently with standard PSG electrodes during the overnight PSG study; estimates AHI, sleep stages, and OSA severity using AASM 1A scoring criteria (desaturation of 3% or more defines hypopnea).

OTHER

CES-EES Clinical Scoring

Combined Clinical Examination Score (CES) and ENT Examination Score (EES), administered via history, oral cavity examination, flexible nasopharyngeal endoscopy, and dental assessment prior to PSG.

Sponsors & Collaborators

  • Belun Technology Company Limited

    collaborator OTHER

  • University of Malaya

    lead OTHER

Principal Investigators

  • Varatha Raju Kugan, MD · Department of Otorhinolaryngology, Head & Neck Surgery, Universiti Malaya Medical Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-03-01
Completion
2027-03-01
FDA Device
Yes

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785999 on ClinicalTrials.gov