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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-11

Study Completion Date

2026-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Validation of the Norbert Health Device for Pulse Rate Measurement

NCT06874504

Healthy

COMPLETED

Validity and Reliability of Optical Heart Rate Sensors

NCT05525000

Health Care Utilization

COMPLETED NA

Pulse Rate and Breathing Rate Accuracy

NCT06298981

Pulse Rate and Breathing Rate

RECRUITING

Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation

NCT05685654

Healthy Hypoxia

UNKNOWN

Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography

NCT04935190

Vital Signs

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Norbert Device

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes