About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Patients with suspected OSA (high ESS and/or STOP-BANG score)
CES-EES score 4 or more
Newly diagnosed cases
Disqualifiers
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
Trial population
Adults referred to the UMMC Otorhinolaryngology sleep clinic for sleep-related breathing disorders and scheduled for in-lab PSG
Trial design
Cohort
Other
Treatments tested in this trial
Belun Ring (Belun Sleep System BLS-100)
DeviceAI/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).
CES-EES Clinical Scoring
Other interventionCombined Clinical Examination Score (CES) and ENT Examination Score (EES), administered via history, oral cavity examination, flexible nasopharyngeal endoscopy, and dental assessment prior to PSG.
Treatment groups
Trial outcomes
Primary outcomes
Apnea-Hypopnea Index (AHI)
AHI (events/hour) derived from polysomnogram or wearable sleep study, scored using AASM 1A criteria (desaturation of 3% or more defines hypopnea); output cross-checked by two independent investigators.
Secondary outcomes
Sleep quality parameters
Total sleep time (TST), sleep latency, wake after sleep onset (WASO), sleep efficiency, and lowest oxygen saturation (LSAT)
Epworth Sleepiness Scale (ESS) score
Self-reported daytime sleepiness questionnaire
Sponsors and contacts
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University of Malaya
Lead sponsor
Belun Technology Company Limited
Collaborator