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

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT06917352
• Lead Sponsor: Norbert Health

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).

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 Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-08
• Study Start: 2025-04-11
• Primary Completion: 2025-04-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10
• Study Completion: 2026-03-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Vigilant Clinical Testing; 🇺🇸 Irvine, California, United States