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

Sponsor
National Jewish Health (Other)
Overall Status
Completed
CT.gov ID
NCT01234077
Collaborator
MyCardio (Other)
50
Enrollment
1
Location
1
Arm
6
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CPC M1
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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.
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
No Intervention: ECG recording

In-laboratory vs. in-home recordings

Device: CPC M1
CPC M1
Other Names:
  • in-laboratory vs. in-home recordings

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder. [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?

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Health Denver Colorado United States 80206

    Sponsors and Collaborators

    • National Jewish Health
    • MyCardio

    Investigators

    • Principal Investigator: John Harrington, MD, National Jewish Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Jewish Health
    ClinicalTrials.gov Identifier:
    NCT01234077
    Other Study ID Numbers:
    • CPC M1
    First Posted:
    Nov 4, 2010
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by National Jewish Health
    scheduled for a polysomnogram (overnight sleep study)
    Additional relevant MeSH terms:
    Sleep Wake Disorders

    Study Results

    No Results Posted as of Jan 19, 2021