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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Malaya

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 volunteers

Qualifiers

≥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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Belun Ring (Belun Sleep System BLS-100)

    Device

    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).

  • CES-EES Clinical Scoring

    Other intervention

    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.

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab P2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

Sleep quality parameters

Total sleep time (TST), sleep latency, wake after sleep onset (WASO), sleep efficiency, and lowest oxygen saturation (LSAT)

Time frame
Baseline
2

Epworth Sleepiness Scale (ESS) score

Self-reported daytime sleepiness questionnaire

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Malaya

Lead sponsor

Belun Technology Company Limited

Collaborator