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

National Jewish Health50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Sleep Disorder

Interventions

CPC M1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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?

Time frame: 6 months