Verification of Computerized Sleep-wake Analysis in Sleep Disorders

Chang Gung Medical Foundation

Status: Unknown

Conditions: Sleep-wake Analysis

Treatments: Other: Patch III heart rate sensor

Study type: Observational

Funder types: Other

Identifiers

NCT02412527

103-5603B

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No 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

Trial design

330 participants in 4 patient groups

Primary insomnia

Description:

Primary insomnia patients, without combined any other sleep disorders

Treatment:

Other: Patch III heart rate sensor

Periodic limb movement in sleep

Description:

Patients have periodic limb movement in sleep, without combined any other sleep disorders

Treatment:

Other: Patch III heart rate sensor

Simple snores

Description:

Simple snore patients, without combined any other sleep disorders

Treatment:

Other: Patch III heart rate sensor

Obstructive sleep apnea

Description:

Obstructive sleep apnea patients, including mild, moderate and severe types, without combined any other sleep disorders or CPAP treatment during PSG study

Treatment:

Other: Patch III heart rate sensor