Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on the CPC M1 Device

Sleep Disorder Clinical Trial

Official title:

A Single Blind Randomized Study Comparing In-laboratory Polysomnography Electrocardiogram to Simultaneously Recorded In-laboratory Electrocardiogram on the CPC M1 Device and Compared to Home Recorded Electrocardiogram With the CPC M1 Device.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234077
• Other study ID #: CPC M1
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: January 2021
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research study that will test a portable device (CPC M1) that records: body movement; heart activity (ECG; snoring; and body position during sleep. The Food and Drug Administration (FDA) has not approved this device for use except in a research setting. The purposes of this study are to: a) determine if the ECG data collected using the CPC M1 device is at least as good as the ECG data collected during a diagnostic, in-lab polysomnogram (PSG) (or sleep study) and b) determine if in-home monitoring with the device will provide similar results compared to an in-lab PSG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adults (males and females) 18 to 70 years of age with a suspected sleep disorder.

2. Subjects or legal guardians are able to verbalize an understanding of the consent form, provide written informed consent, and verbalize willingness to complete study procedures.

3. Adequate dexterity to apply and remove the CPC M1 device.

Exclusion Criteria:

1. Patients with atrial fibrillation and ventricular tachycardia.

2. Patients with an inability to apply the CPC M1 device.

3. Pregnancy.

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• CPC M1
CPC M1

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	MyCardio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.	Does the ECG-based data obtained from a portable device correlate to a similar analysis of simultaneously recorded ECG data obtained from standard polysomnography?	6 months
Primary	Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.	What is the sensitivity/specificity of the ECG-based method recorded in-lab vs. in the home.	6 months