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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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01234077
Study type Interventional
Source National Jewish Health
Contact
Status Completed
Phase N/A
Start date March 2010
Completion date September 2010
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