Healthy
Conditions
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 reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of subjects.
Interventions
DEVICENorbert Device
The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of pulse rate.
Sponsors
Vigilant Clinical Testing
Norbert Health
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria: * 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | Approximately 1 hour | To validate the accuracy specification for pulse rate from the ND when compared to an FDA-cleared medical device for heart rate monitoring electrocardiogram (ECG monitor, 5 lead). Acceptance criteria for the overall cohort is ≤ 3.0 bpm for PR in subjects compared to a gold standard ECG. |
Countries
United States
Outcome results
None listed