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Diagnostic Accuracy of the Belun Ring in Children at Risk of Obstructive Sleep Apnea

Completed
Conditions
Children aged 5-18 years with suspected OSA
obstructive sleep apnea, pediatric, sleep, polysomnography, wearable electronic devices
Registration Number
TCTR20240604003
Lead Sponsor
King Chulalongkorn Memorial Hospital
Brief Summary

The B-AHI had a moderate positive correlation with the P-AHI. The mean difference between B-AHI and P-AHI of -7.8 events/hour. Area under the ROC curve of the Belun ring to detect moderate-to-severe OSA was 0.66. The best single cut-off of B-AHI was 3 events/hour (sensitivity 74.1% and specificity 52.4%).

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
75
Inclusion Criteria

Children aged 5-18 years with clinically suspected OSA who were going to undertake PSG

Exclusion Criteria

1. Patients with cardiac arrhythmia or peripheral vascular disease
2. Patients who received full-night PAP titration during PSG
3. Total recording time < 4 hours

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy At the time that patients monitored with overnight PSG Correlation and agreement of Belun ring AHI compared with PSG AHI
Secondary Outcome Measures
NameTimeMethod
Diagnostic accuracy At the time that patients monitored with overnight PSG Sensitivity, Specificity, PPV, NPV, AUROC at different cut-points of Belun AHI for detecting moderate to severe OSA
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