Trial record 6 of 2305 for:    electrocardiogram

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: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Sleep Disorder
Device: CPC M1

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ECG recording
In-laboratory vs. in-home recordings
Device: CPC M1
CPC M1
Other Name: in-laboratory vs. in-home recordings

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234077

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
MyCardio
Investigators
Principal Investigator: John Harrington, MD National Jewish Health
  More Information

No publications provided by National Jewish Health

Additional 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
Study First Received: October 29, 2010
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 01, 2014