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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Sleep Disorder

Intervention / Treatment
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* Device: CPC M1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ECG recording<br>In-laboratory vs. in-home recordings | Device: CPC M1<br>* CPC M1<br>* Other names: in-laboratory vs. in-home recordings;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scheduled for a polysomnogram (overnight sleep study)