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

Completed · Not applicable

Conditions studied: Sleep Disorder

In brief

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.

Key facts

Study ID

NCT01234077

Run by

National Jewish Health

People needed

50

Starts

2010-03-01

Expected to finish

2010-09-01

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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