Verification of Computerized Sleep-wake Analysis in Sleep Disorders

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02412527

Enrollment

330

Registered

2015-04-09

Start date

2015-04-30

Completion date

Unknown

Last updated

2015-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep-wake Analysis

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.

Interventions

OTHERPatch III heart rate sensor

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Contacts

Primary ContactGeng-Hao Liu

wisdomhao@gmail.com+886-3-3196200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026