Clinical Validation of the Norbert Health Device for Pulse Rate Measurement at Vigilant Clinical Testing

N/AActive Not RecruitingNCT06917352

Norbert Health40 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy

Interventions

Norbert DeviceDEVICE

The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of pulse rate.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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

Locations (1)

Vigilant Clinical Testing

Irvine, California, United States

Outcomes

Primary Outcomes

Primary Objective

To validate the accuracy specification for pulse rate from the ND when compared to an FDA-cleared medical device for heart rate monitoring electrocardiogram (ECG monitor, 5 lead). Acceptance criteria for the overall cohort is ≤ 3.0 bpm for PR in subjects compared to a gold standard ECG.

Time frame: Approximately 1 hour

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.