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

Not Applicable

Completed

• Conditions: Sleep Disorder
• Interventions: Device: CPC M1

• Registration Number: NCT01234077
• Lead Sponsor: National Jewish Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECG recording	CPC M1	In-laboratory vs. in-home recordings

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.	6 months	What is the sensitivity/specificity of the ECG-based method recorded in-lab vs. in the home.

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States