Analyze Sleep Stages by Portable ECG Device

Obstructive Sleep Apnea Clinical Trial

Official title:

Analyze Sleep Stages by Portable ECG Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765958
• Other study ID #: FEMH-104181-F
• Status: Completed
• Phase: N/A
• First received: May 4, 2016
• Last updated: February 7, 2018
• Start date: May 4, 2016
• Est. completion date: August 2, 2017

Study information

• Verified date: February 2018
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• OSA: OPD OSA patients; Healthy: no OSA

Exclusion Criteria:

• heart disease

• arrhythmia

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• portable ECG devise

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RR interval changes compared to the report of polysomography	The difference of RR interval in healthy subjects and obstructive sleep apnea subjects	8 hours