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| Name | Class |
|---|---|
| MyCardio | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECG recording | No Intervention | In-laboratory vs. in-home recordings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPC M1 | Device | CPC M1 |
|
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Harrington, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28884264 | Derived | 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. | |
| 23354509 | 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. |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D001523 | Mental Disorders |