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

• Conditions: Vital Signs
• Interventions: Diagnostic Test: Vitalpercept

• Registration Number: NCT04935190
• Lead Sponsor: DawnLight

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-14
• Study Start: 2021-06-15
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-22
• Primary Completion: 2021-07-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Measurement of Respiratory Rate	During Data collection-Expected time=45-60 minutes	Effectiveness
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

Trial Locations

Locations (1)

North Carolina Clinical Research; 🇺🇸 Raleigh, North Carolina, United States