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

D

DawnLight

Status

Unknown

Conditions

Vital Signs

Treatments

Diagnostic Test: Vitalpercept

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

  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.

Enrollment

100 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Group 1
Description:
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.
Treatment:
Diagnostic Test: Vitalpercept
Group 2
Description:
Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.
Treatment:
Diagnostic Test: Vitalpercept

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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