Analyze Sleep Stages by Portable ECG Device

NCT02765958 | Completed DMC

• 1 other identifier: FEMH-104181-F
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• RR interval changes compared to the report of polysomography

  The difference of RR interval in healthy subjects and obstructive sleep apnea subjects

  8 hours

Study Arms (2)

Healthy

subjects without heart disease or arrhythmia, no evidence of obstructive sleep apnea

Device: portable ECG devise

OSA

obstructive sleep apnea

Device: portable ECG devise

Interventions

portable ECG devise DEVICE

Healthy; OSA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

outpatient in chest clinic

You may qualify if:

• OSA: OPD OSA patients; Healthy: no OSA

You may not qualify if:

• heart disease
• arrhythmia

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ping-huai Wang, MD

  Far Eastern Memeorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 9, 2016
• Study Start: May 4, 2016
• Primary Completion: February 27, 2017
• Study Completion: August 2, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)