Status:
ACTIVE_NOT_RECRUITING
Clinical Validation of the Norbert Health Device for Pulse Rate Measurement at Vigilant Clinical Testing
Lead Sponsor:
Norbert Health
Collaborating Sponsors:
Vigilant Clinical Testing
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Brief Summary
The study will evaluate the measuring pulse rate (PR) using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
Detailed Description
The study design is to validate the pulse rate accuracy. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a...
Eligibility Criteria
Inclusion
- Subjects must be 18 years or older
- Ability to comprehend written consent and provide informed consent
- Ability to commit to and complete study related paperwork and activities (i.e. subject forms, have de-identified pictures taken, comply with periods of no movement, etc.)
Exclusion
- Pregnant women
- Diagnosis of essential tremor or any medical condition causing tremors of the head or hands
- Facial tattoos, scars, large moles, beards/hair growth, birthmarks, vitiligo, skin conditions, facial discoloration, or heavy makeup within the areas of interest
- Inability for subject to avoid extreme movement during measurement reading windows
- Inability for subject to raise their hand during measurement reading windows
- No heart arrythmias
- Discretion of the Principal investigator or clinical study staff
Key Trial Info
Start Date :
April 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 5 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06917352
Start Date
April 11 2025
End Date
March 5 2026
Last Update
June 10 2025
Active Locations (1)
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1
Vigilant Clinical Testing
Irvine, California, United States, 92618