RecruitingNCT07785999

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

Validation of Clinical Upper Airway Assessment Tool With Artificial Intelligence Wearable Technology Against In-Lab Polysomnography


Sponsor

University of Malaya

Enrollment

58 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Belun Ring (Belun Sleep System BLS-100) and CES-EES Clinical Scoring for people with obstructive sleep apnea. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBelun 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).

OTHERCES-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.


Locations(1)

Universiti Malaya Medical Centre (UMMC)

Pantai Valley, Kuala Lumpur, Malaysia

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NCT07785999


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