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

Vital Signs Clinical Trial

— Vitalpercept  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04935190
• Other study ID #: CP001
• Status: Active, not recruiting
• Start date: June 15, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: August 2021
• Source: DawnLight
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vital Signs

Intervention

Diagnostic Test:
• Vitalpercept
Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography

Locations

Country	Name	City	State
United States	North Carolina Clinical Research	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
DawnLight

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse events	Safety	During Data collection-Expected time=45-60 minutes
Primary	Measurement of Heart Rate	Effectiveness	During Data collection-Expected time=45-60 minutes
Primary	Measurement of Respiratory Rate	Effectiveness	During Data collection-Expected time=45-60 minutes