Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Norbert Health
With
Vigilant Clinical Testing
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.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.)
You may not be if
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
Clareo Health | Clinical Validation of the Norbert Health Device for Pulse Rate Measurement at Vigilant Clinical Testing
