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Clinical Trials in the USA / NCT06917352
Active, not recruiting Observational

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

NCT06917352 · tracked via the Priya Life Science USA tracker
Sponsor
Norbert Health
Phase
Observational
Started
2025-04-11
Last updated
2025-06-10

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Norbert Device

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Primary Objective — Approximately 1 hour
    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.

Trial sites (1)

FacilityCityRegionStatus
Vigilant Clinical Testing Irvine California

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06917352 on ClinicalTrials.gov ↗ ← All trials in the USA