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

Primary Purpose

Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPC M1
Sponsored by
National Jewish Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Disorder focused on measuring scheduled for a polysomnogram (overnight sleep study)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Jewish Health

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

ECG recording

Arm Description

In-laboratory vs. in-home recordings

Outcomes

Primary Outcome Measures

Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.
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.
What is the sensitivity/specificity of the ECG-based method recorded in-lab vs. in the home.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2010
Last Updated
January 15, 2021
Sponsor
National Jewish Health
Collaborators
MyCardio
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1. Study Identification

Unique Protocol Identification Number
NCT01234077
Brief Title
Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on the CPC M1 Device
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
MyCardio

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
scheduled for a polysomnogram (overnight sleep study)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECG recording
Arm Type
No Intervention
Arm Description
In-laboratory vs. in-home recordings
Intervention Type
Device
Intervention Name(s)
CPC M1
Other Intervention Name(s)
in-laboratory vs. in-home recordings
Intervention Description
CPC M1
Primary Outcome Measure Information:
Title
Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.
Description
Does the ECG-based data obtained from a portable device correlate to a similar analysis of simultaneously recorded ECG data obtained from standard polysomnography?
Time Frame
6 months
Title
Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.
Description
What is the sensitivity/specificity of the ECG-based method recorded in-lab vs. in the home.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Harrington, MD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28884264
Citation
Magnusdottir S, Hilmisson H. Ambulatory screening tool for sleep apnea: analyzing a single-lead electrocardiogram signal (ECG). Sleep Breath. 2018 May;22(2):421-429. doi: 10.1007/s11325-017-1566-6. Epub 2017 Sep 7.
Results Reference
derived
PubMed Identifier
23354509
Citation
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.
Results Reference
derived

Learn more about this trial

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

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