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

This study has been completed.
Sponsor:
Collaborator:
MyCardio
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health
ClinicalTrials.gov Identifier:
NCT01234077
First received: October 29, 2010
Last updated: September 24, 2014
Last verified: September 2014

October 29, 2010
September 24, 2014
March 2010
September 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01234077 on ClinicalTrials.gov Archive Site
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Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on the CPC M1 Device
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Sleep Disorder
Device: CPC M1
CPC M1
Other Name: in-laboratory vs. in-home recordings
No Intervention: ECG recording
In-laboratory vs. in-home recordings
Intervention: Device: CPC M1
Harrington J, Schramm PJ, Davies CR, Lee-Chiong TL Jr. An electrocardiogram-based analysis evaluating sleep quality in patients with obstructive sleep apnea. Sleep Breath. 2013 Sep;17(3):1071-8. doi: 10.1007/s11325-013-0804-9. Epub 2013 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01234077
CPC M1
No
Jennifer Brandorff, National Jewish Health
National Jewish Health
MyCardio
Principal Investigator: John Harrington, MD National Jewish Health
National Jewish Health
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP