NCT06917352

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Norbert Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2025-04-11
• Primary completion: 2025-04-13
• Completion: 2026-03-05
• First posted: 2025-04-08
• Last updated: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study