Obstructive Sleep Apnea Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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)

Locations
Other Locations
Malaysia
Universiti Malaya Medical Centre (UMMC)
RECRUITING
Pantai Valley
Contact Information
Primary
Dr. Kugan a/l Varatha Raju, MD
kugan.varatha@ummc.edu.my
+6012-4559957
Backup
Associate Professor Dr. Goh Liang Chye, MBBS
gohlc@ummc.edu.my
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 58
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Malaya
Collaborators: Belun Technology Company Limited

This content was sourced from clinicaltrials.gov