Skip to main content
OpenTrials
Completed

NCT Number: NCT01234077

Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Health

Denver, Colorado, 80206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (males and females) 18 to 70 years of age with a suspected sleep disorder.
  • 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.
  • Adequate dexterity to apply and remove the CPC M1 device.

Exclusion criteria

  • Patients with atrial fibrillation and ventricular tachycardia.
  • Patients with an inability to apply the CPC M1 device.
  • Pregnancy.

Treatment and study plan

CPC M1

Device

CPC M1

Other names: in-laboratory vs. in-home recordings

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • MyCardio

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 4, 2010
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.