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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
Information provided by (Responsible Party):

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
Sleep Disorder Device: CPC M1

Study Design

Study Type : Interventional  (Clinical Trial)
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 : March 2010
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: ECG recording
In-laboratory vs. in-home recordings
Device: CPC M1
Other Name: 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. [ 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?

  2. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

Information from the National Library of Medicine

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
Sponsors and Collaborators
National Jewish Health
Principal Investigator: John Harrington, MD National Jewish Health
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jennifer Brandorff, Regulatory Manager, National Jewish Health
ClinicalTrials.gov Identifier: NCT01234077     History of Changes
Other Study ID Numbers: CPC M1
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Jennifer Brandorff, National Jewish Health:
scheduled for a polysomnogram (overnight sleep study)

Additional relevant MeSH terms:
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders