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

NCT01234077 | Completed

• 1 other identifier: CPC M1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Keywords

scheduled for a polysomnogram (overnight sleep study)

Outcome Measures

Primary Outcomes (2)

• 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?

  6 months

• 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.

  6 months

Study Arms (1)

ECG recording

NO INTERVENTION

In-laboratory vs. in-home recordings

Device: CPC M1

Interventions

CPC M1 DEVICE

CPC M1

Also known as: in-laboratory vs. in-home recordings

ECG recording

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Jewish Health: lead
• MyCardio: collaborator

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (2)

• 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.

  PMID: 28884264 DERIVED

• 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.

  PMID: 23354509 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• John Harrington, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 4, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

US (1)