Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
1 other identifier
observational
37
1 country
2
Brief Summary
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
December 7, 2022
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2023
CompletedDecember 20, 2023
December 1, 2023
5 months
November 28, 2022
December 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Average Error (MAE)
MAE will be evaluated by Mean absolute error (MAE) of the pulse rate of the device compared to the heart rate measured from the RCECG.
Up to 1 hour
Interventions
The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.
Eligibility Criteria
The study will recruit subjects within an Emergency Department as well as through online internet bulletin boards.
You may qualify if:
- Male or female subjects aged 18 or over
- Ability to provide signed informed consent
You may not qualify if:
- Pregnant
- Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norbert Healthlead
- Northwell Healthcollaborator
Study Sites (2)
Newlab
Brooklyn, New York, 11205, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2022
First Posted
December 7, 2022
Study Start
April 26, 2023
Primary Completion
October 4, 2023
Study Completion
October 20, 2023
Last Updated
December 20, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share