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

Clinical Validation of the Norbert Health Device for Pulse Rate Measurement

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Norbert Device

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Vigilant Clinical Testing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects 18 years of age or older with the ability to consent to study and follow instructions needed for data collection. Data will be collected on enrolled patients including but not limited to diabetes, hypertension, cardiac conditions, circulation problems, medications, and other health issues that would affect blood circulation to skin. Subject enrollment for these comorbidities and others will be based on incidental enrollment from the pool of available subjects per site.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 1 hour

Collaborators and Investigators

• Sponsor: Norbert Health
• Collaborators: Vigilant Clinical Testing
• Investigators: Principal Investigator: Tala Harake, Masters of Science, Vigilant Clinical Testing

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Actual): April 13, 2025
• Study Completion (Estimated): March 5, 2026

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NCP-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No