An observational study in Healthy, sponsored by Norbert Health. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Norbert Health · Observational
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).
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.
Norbert Health is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Exclusion Criteria:
The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of pulse rate.
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.
Time frame: Approximately 1 hour
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Norbert Health