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

Norbert Health

Status: Completed

Conditions: Arrhythmia; Healthy

Treatments: Device: Norbert Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05640323

NCP-0002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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