Analyze Sleep Stages by Portable ECG Device

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: portable ECG devise

• Registration Number: NCT02765958
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

Sleep is a fundamental need for human and is associated with the working performance and the disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more important recently. In clinical settings, the analysis of daily sleep quality depends on actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really convenient for patients. In this trial, the investigators will measure the subjects' ECG signal and movement using a portable ECG device with motion sensor. On the other hand, the sleep stages are also obtained from the current wide-established measurement- polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our algorithm of artificial neural network. Then, the investigators can obtain the preliminary analysis of sleep quality can be obtained by using ECG device with our algorithm. It is helpful for doctors to realize the patent's sleep quality quickly

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-04
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-09
• Primary Completion: 2017-02-27
• Study Completion: 2017-08-02
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• OSA: OPD OSA patients; Healthy: no OSA

Exclusion Criteria

• heart disease
• arrhythmia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	portable ECG devise	subjects without heart disease or arrhythmia, no evidence of obstructive sleep apnea
OSA	portable ECG devise	obstructive sleep apnea

Primary Outcome Measures

Name	Time	Method
RR interval changes compared to the report of polysomography	8 hours	The difference of RR interval in healthy subjects and obstructive sleep apnea subjects

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei, Taiwan