Verification of Computerized Sleep-wake Analysis in Sleep Disorders

• Conditions: Sleep-wake Analysis

• Registration Number: NCT02412527
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Objective: Computerized sleep staging has been verified in a normal population. This study attempts to investigate and verify the interpretation of this computerized sleep staging program in patients with sleep disorders, and improve the accuracy of actigraphy algorithm for sleep duration and postures.

1. Compare the accuracy of computerized sleep-wake analysis with current sleep quality indicators: through actigraphy and heart rate sensors, compare the computerized sleep-wake analysis program with polysomnography, and verify its clinical reliability and validity in sleep disorder patients.

2. Establish the sleep posture detection system: through three-axis accelerometer, develop algorithms for position recording and monitoring during sleep, and upgrade its accuracy according to photography.

Methods: Patients ranged from age 20-50 with primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea will be enrolled in our study. Routine polysomnography will be applied in sleep center at Chang Gung Memorial Hospital, Taoyuan, as well as sleep-related questionnaires. At the same time, actigraphy and heart rate sensor patch will be used for sleep posture detection and further computerized sleep-wake analysis. Results will be verified the consistency by comparison with sleep-wake analysis from polysomnographic data and sleep-related questionnaires.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-06
• Last Update Submitted: 2015-04-06
• Study First Posted: 2015-04-09
• Last Update Posted: 2015-04-09
• Primary Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• age 20-50
• diagnosed as primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea

Exclusion Criteria

• arrhythmia
• sleep efficiency<50%
• combined other sleep disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electrocardiogram and body position signals	Data recruited during one-night (PSG study) from Patch III heart rate sensor	Computerized sleep-wake analysis from electrocardiogram and body position signals from Patch III heart rate sensor, and calibrated the sleep staging with AASM sleep scoring reports.