Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on the CPC M1 Device
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|ClinicalTrials.gov Identifier: NCT01234077|
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : March 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorder||Device: CPC M1||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
No Intervention: ECG recording
In-laboratory vs. in-home recordings
Device: CPC M1
Other Name: in-laboratory vs. in-home recordings
- Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder. [ Time Frame: 6 months ]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 ]What is the sensitivity/specificity of the ECG-based method recorded in-lab vs. in the home.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234077
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|Principal Investigator:||John Harrington, MD||National Jewish Health|