Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate

Norbert Health37 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy Arrhythmia

Interventions

Norbert DeviceDEVICE

The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects aged 18 or over * Ability to provide signed informed consent Exclusion Criteria: * Pregnant * Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator

Locations (2)

Newlab

Brooklyn, New York, United States

Staten Island University Hospital

Staten Island, New York, United States

Outcomes

Primary Outcomes

Mean Average Error (MAE)

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.

Time frame: Up to 1 hour

Data from ClinicalTrials.gov

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