NCT07785999

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 16, 2026

Last Update Submit

August 21, 2026

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneasleep parameterspolysomnographywearable devicediagnostic accuracy

Outcome Measures

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.

    Baseline

Secondary Outcomes (2)

  • Sleep quality parameters

    Baseline

  • Epworth Sleepiness Scale (ESS) score

    Baseline

Study Arms (1)

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

Device: Belun Ring (Belun Sleep System BLS-100)Other: CES-EES Clinical Scoring

Interventions

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).

Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab P
CES-EES Clinical ScoringOTHER

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.

Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab P

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults referred to the UMMC Otorhinolaryngology sleep clinic for sleep-related breathing disorders and scheduled for in-lab PSG

You may qualify if:

  • ≥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)

You may not qualify if:

  • 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
  • Active respiratory or neurological disorders
  • Active psychiatric disorders and currently on psychiatric medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Malaya Medical Centre (UMMC)

Pantai Valley, Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Publications (6)

  • Strumpf Z, Gu W, Tsai CW, Chen PL, Yeh E, Leung L, Cheung C, Wu IC, Strohl KP, Tsai T, Folz RJ, Chiang AA. Belun Ring (Belun Sleep System BLS-100): Deep learning-facilitated wearable enables obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification in patients suspected of obstructive sleep apnea. Sleep Health. 2023 Aug;9(4):430-440. doi: 10.1016/j.sleh.2023.05.001. Epub 2023 Jun 26.

    PMID: 37380590BACKGROUND

  • 6. Hasan KIB, Lim KS, Goh LC, Fong SL, Ramanaidu LP, Lee ZY, Tan CT. Sequential screenings improve prediction in obstructive sleep apnoea severity. Neurology Asia. 2025;30(2):571-585.

    BACKGROUND

  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

    PMID: 1798888BACKGROUND

  • Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.

    PMID: 18431116BACKGROUND

  • Gottlieb DJ, Punjabi NM. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA. 2020 Apr 14;323(14):1389-1400. doi: 10.1001/jama.2020.3514.

    PMID: 32286648BACKGROUND

  • 1. American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.

    BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Varatha Raju Kugan, MD

    Department of Otorhinolaryngology, Head & Neck Surgery, Universiti Malaya Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Kugan a/l Varatha Raju, MD

CONTACT

+6012-4559957kugan.varatha@ummc.edu.my

Associate Professor Dr. Goh Liang Chye, MBBS

CONTACT

gohlc@ummc.edu.my

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr

Study Record Dates

First Submitted

August 16, 2026

First Posted

August 25, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)