Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on the CPC M1 Device
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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.|
- Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Does the ECG-based data obtained from a portable device correlate to a similar analysis of simultaneously recorded ECG data obtained from standard polysomnography?
- Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder. [ Time Frame: 6 months ] [ Designated as safety issue: No ]What is the sensitivity/specificity of the ECG-based method recorded in-lab vs. in the home.
|Study Start Date:||March 2010|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
No Intervention: ECG recording
In-laboratory vs. in-home recordings
Device: CPC M1
Other Name: in-laboratory vs. in-home recordings
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|Principal Investigator:||John Harrington, MD||National Jewish Health|