Vital Signs
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTVitalpercept
Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography
Sponsors
DawnLight
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse events | During Data collection-Expected time=45-60 minutes | Safety |
| Measurement of Heart Rate | During Data collection-Expected time=45-60 minutes | Effectiveness |
| Measurement of Respiratory Rate | During Data collection-Expected time=45-60 minutes | Effectiveness |
Countries
United States
Outcome results
None listed