Status:
RECRUITING
Data Collection and Evaluation of OptiBP Under Investigational Use
Lead Sponsor:
Biospectal
Conditions:
General Population
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to collect data to develop and evaluate the use of state-of-the-art machine learning approaches within a mobile phone application for the estimation of blood pressure.
Detailed Description
Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor on the upper arm, while recording an optical signal throug...
Eligibility Criteria
Inclusion
- Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
- Live in the United States of America
- Have an Android smartphone
- Have access to an arm-worn blood pressure monitor (cuff)
- Have access to the Google Play store to download the OptiBP study app on their phone
- Be comfortable communicating in written and spoken English
- Be willing and able to provide informed consent to participate in the study
Exclusion
- Known contact dermatitis to nickel/chromium
- Lesion or deficiency on hand, preventing placing a finger on the smartphone camera
- Known dysrhythmia like bigeminy, trigeminy, isolated VPB, atrial fibrillation
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
500000 Patients enrolled
Trial Details
Trial ID
NCT06017687
Start Date
September 28 2023
End Date
September 1 2026
Last Update
September 29 2023
Active Locations (1)
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1
Decentralized Trial
Truckee, California, United States, 96161