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

NCT ID: NCT04935190

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2021-10-30

Brief Summary

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

Detailed Description

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Conditions

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Vital Signs

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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.

Vitalpercept

Intervention Type DIAGNOSTIC_TEST

Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography

Group 2

Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.

Vitalpercept

Intervention Type DIAGNOSTIC_TEST

Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography

Interventions

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Vitalpercept

Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects ≥ 21 years of age at the time of signing the informed consent.
2. Subjects willing to sign the informed consent and capable of committing to the duration of the study.
3. Subjects with the ability to lie flat, lie on left side, lie on right side, and sit in a chair.
4. Subjects who are able to breathe through their nose for the capnography assessment.
5. 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.
6. Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.

Exclusion Criteria

1. Subjects who are prone to excessive coughing and excessive movement
2. Subjects who have a condition that involves uncontrollable movement of the body such as Parkinson's Disease or Essential Tremor.
3. Subjects with a history of allergy to adhesive, latex or Nuprep.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DawnLight

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CP001

Identifier Type: -

Identifier Source: org_study_id