HealthyNCT06917352
Clinical Validation of the Norbert Health Device for Pulse Rate Measurement at Vigilant Clinical Testing
An observational study of Healthy, run by Norbert Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Norbert Device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to 5 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of the Norbert Health Device for Pulse Rate Measurement
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).
Read the 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
- Being tested
- Norbert Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norbert DeviceDevice
The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of pulse rate.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start11 Apr 2025
- Primary completion13 Apr 2025
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norbert Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vigilant Clinical Testing
- Responsible party
- Sponsor
- Investigators
- Tala Harake, Masters of Science, Principal investigator, Vigilant Clinical Testing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917352
- Sponsor's protocol ID
- NCP-0005
- Status last verified
- Jun 2025
- First submitted
- 25 Mar 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Norbert Health Device for Pulse Rate Measurement
- ClinicalTrials.gov ID
- NCT06917352
- Acronym / sponsor ID
- NCP-0005
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Norbert HealthIndustry (pharma, biotech, devices)
- Collaborators
- Vigilant Clinical Testing
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 5 Mar 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norbert DeviceThe Norbert Device (ND) is a contactless, noninvasive device that provides measurements of pulse rate. | Device | – |
Primary outcome
Primary Objective
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tala Harake, Masters of Science principal investigator
Vigilant Clinical Testing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Norbert Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: Approximately 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.