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

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.

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.

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.