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

NCT04935190 | Unknown FDA Device

• 1 other identifier: CP001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vital Signs

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Diagnostic Test: Vitalpercept

Group 2

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

Diagnostic Test: Vitalpercept

Interventions

Vitalpercept DIAGNOSTIC_TEST

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

Group 1; Group 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DawnLight: lead

Study Sites (1)

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: June 15, 2021
• Primary Completion: July 30, 2021
• Study Completion: October 30, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)