Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
- Conditions
- HealthyArrhythmia
- Registration Number
- NCT05640323
- Lead Sponsor
- Norbert Health
- Brief Summary
The study will evaluate the mean average error (MAE) of measuring pulse rate 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 and heart rate accuracy as required per ISO 80601-2-61, Clause 201.12.1.104. 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 types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- Male or female subjects aged 18 or over
- Ability to provide signed informed consent
- Pregnant
- Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Average Error (MAE) Up to 1 hour MAE will be evaluated by Mean absolute error (MAE) of the pulse rate of the device compared to the heart rate measured from the RCECG.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Newlab
🇺🇸Brooklyn, New York, United States