[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653330":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":23,"studyPopulation":24,"armGroups":25,"interventions":32,"overallOfficials":42,"centralContacts":47,"locations":56,"responsibleParty":78,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":20,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":20,"enrollmentInfo":93,"targetDuration":96,"studyType":97,"phases":20,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":59,"whyStopped":20,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Malaya","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Apnea-Hypopnea Index (AHI)","AHI (events\u002Fhour) 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",[14,17],{"measure":15,"description":16,"timeFrame":12},"Sleep quality parameters","Total sleep time (TST), sleep latency, wake after sleep onset (WASO), sleep efficiency, and lowest oxygen saturation (LSAT)",{"measure":18,"description":19,"timeFrame":12},"Epworth Sleepiness Scale (ESS) score","Self-reported daytime sleepiness questionnaire",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":6,"maskingInfo":20},"COHORT","Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder associated with cardiovascular, cerebrovascular, and other long-term health consequences if untreated. In-lab polysomnography (PSG) is the diagnostic reference standard but is resource-intensive, costly, and associated with long waiting times. Existing screening tools such as the STOP-BANG questionnaire and the Epworth Sleepiness Scale (ESS) have recognized sensitivity\u002Fspecificity trade-offs. The Clinical Examination Score (CES) combined with the ENT Examination Score (EES) is a previously described clinical scoring tool for OSA screening. The Belun Ring (Belun Sleep System BLS-100) is an FDA 510(k)-cleared (Class II), Malaysia Medical Device Authority-registered, AI\u002Fdeep-learning-facilitated wearable capable of estimating AHI, sleep staging, and OSA severity.\n\nThis is a prospective, comparative, single-centre study conducted at Universiti Malaya Medical Centre (UMMC). Adults referred to the Otorhinolaryngology sleep clinic for suspected OSA, with high ESS and\u002For STOP-BANG scores, are screened with the CES-EES; those scoring 4 or more and otherwise meeting eligibility criteria are enrolled. After informed consent, participants undergo a standardised history, demographic data collection, and physical examination (oral cavity examination, flexible nasopharyngeal endoscopy, dental assessment), followed by a single overnight Level 1 in-lab PSG (Compumedics, 7-channel) at the UMMC Neurology Sleep Lab. The Belun Ring is fitted to the participant's index finger concurrently with standard PSG electrodes, so both devices record simultaneously during the same overnight study. A minimum of 4 hours total sleep time (TST) is required; participants with less than 4 hours TST are excluded from analysis. Both PSG and Belun Ring AHI are scored using AASM 1A criteria (hypopnea defined by desaturation of 3% or more). PSG is manually scored by a sleep technician; Belun Ring output is processed by the device's AI algorithm and independently cross-checked by two investigators.\n\nThe primary comparisons are: (1) CES-EES score against PSG AHI; (2) Belun Ring AHI against PSG AHI; and (3) CES-EES combined with Belun Ring AHI against PSG AHI. Planned statistical analyses include the paired t-test or Wilcoxon signed-rank test for comparative analysis, Bland-Altman plots for agreement\u002Fbias analysis, the intraclass correlation coefficient (ICC) for inter-scorer reliability, and descriptive statistics (mean, median, SD, range).","Adults referred to the UMMC Otorhinolaryngology sleep clinic for sleep-related breathing disorders and scheduled for in-lab PSG",[26],{"label":27,"type":20,"description":28,"interventionNames":29},"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",[30,31],"Device: Belun Ring (Belun Sleep System BLS-100)","Other: CES-EES Clinical Scoring",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":20},"DEVICE","Belun Ring (Belun Sleep System BLS-100)","AI\u002Fdeep-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).",[27],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":20},"CES-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.",[27],[43],{"name":44,"affiliation":45,"role":46},"Varatha Raju Kugan, MD","Department of Otorhinolaryngology, Head & Neck Surgery, Universiti Malaya Medical Centre","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":20,"email":52},"Dr. Kugan a\u002Fl Varatha Raju, MD","CONTACT","+6012-4559957","kugan.varatha@ummc.edu.my",{"name":54,"role":50,"phone":20,"phoneExt":20,"email":55},"Associate Professor Dr. Goh Liang Chye, MBBS","gohlc@ummc.edu.my",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Universiti Malaya Medical Centre (UMMC)","RECRUITING","Pantai Valley","Kuala Lumpur","59100","Malaysia","MY",{"type":66,"coordinates":67},"Point",[68,69],101.66667,3.11667,{"lat":69,"lon":68},[72,73,76],{"name":44,"role":46,"phone":20,"phoneExt":20,"email":20},{"name":74,"role":75,"phone":20,"phoneExt":20,"email":20},"Liang Chye Goh, MBBS","SUB_INVESTIGATOR",{"name":77,"role":75,"phone":20,"phoneExt":20,"email":20},"Kheng Seng Lim, MBBS",{"type":46,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Goh Liang Chye","Associate Professor Dr",[82],{"name":83,"class":6},"Belun Technology Company Limited","100653330","ces-ees-clinical-score-and-a-wearable-ring-sensor-for-obstructive-sleep-apnea-individual-and-combined-validation-against-in-laboratory-polysomnography-100653330",false,"NCT07785999","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","Inclusion Criteria:\n\n* ≥18 years old\n* Patients with suspected OSA (high ESS and\u002For STOP-BANG score)\n* CES-EES score 4 or more\n* Newly diagnosed cases\n* Minimum 4 hours of Total Sleep Time (TST)\n\nExclusion Criteria:\n\n* Active URTI (upper respiratory tract infection) in the past 1 month\n* Current smoker\n* Alcohol consumption within 8 hours prior to testing\n* History of head and neck carcinoma\n* Active respiratory or neurological disorders\n* Active psychiatric disorders and currently on psychiatric medication","ALL","18 Years",{"count":94,"type":95},58,"ESTIMATED","6 Months","OBSERVATIONAL","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.",[100],"Obstructive Sleep Apnea",[102,103,104,105,106],"obstructive sleep apnea","sleep parameters","polysomnography","wearable device","diagnostic accuracy","2026-08-21",{"date":109,"type":110},"2026-08-25","ACTUAL",{"date":112,"type":110},"2026-03-01",{"date":114,"type":95},"2027-03-01",{"name":5,"class":6},1]