Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography

Study Overview
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Brief Summary
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Determine agreement (accuracy) of resting heart rate measured by Vitalpercept when compared to an FDA-cleared electrocardiograph (ECG) device, LifeSignals Wireless Biosensor. Determine agreement (accuracy) of resting respiratory rate measured by Vitalpercept when compared to an FDA-cleared capnographer, Capnostream 20.

Official Title
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Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography

Conditions
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Vital Signs

Intervention / Treatment
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* Diagnostic Test: Vitalpercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects ≥ 21 years of age at the time of signing the informed consent. Subjects willing to sign the informed consent and capable of committing to the duration of the study. Subjects with the ability to lie flat, lie on left side, lie on right side, and sit in a chair. Subjects who are able to breathe through their nose for the capnography assessment. Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1. Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2. Exclusion Criteria: Subjects who are prone to excessive coughing and excessive movement Subjects who have a condition that involves uncontrollable movement of the body such as Parkinson's Disease or Essential Tremor. Subjects with a history of allergy to adhesive, latex or Nuprep.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1. | Diagnostic Test: Vitalpercept<br>* Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography<br>|
| Group 2<br>Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2. | Diagnostic Test: Vitalpercept<br>* Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse events | Safety | During Data collection-Expected time=45-60 minutes | 
| Measurement of Heart Rate | Effectiveness | During Data collection-Expected time=45-60 minutes | 
| Measurement of Respiratory Rate | Effectiveness | During Data collection-Expected time=45-60 minutes |