Clinical Validation of the Norbert Health Device for Pulse Rate Measurement

Norbert Health

Status: Completed

Conditions: Healthy

Treatments: Device: Norbert Device

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06874504

NCP-0004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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