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

NCT06917352 | Active Not Recruiting FDA Device

• 1 other identifier: NCP-0005
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Norbert Device DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norbert Health: lead
• Vigilant Clinical Testing: collaborator

Study Sites (1)

Vigilant Clinical Testing

Irvine, California, 92618, United States

Location

Study Officials

• Tala Harake, Masters of Science

  Vigilant Clinical Testing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 8, 2025
• Study Start: April 11, 2025
• Primary Completion: April 13, 2025
• Study Completion: March 5, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)