Data Collection and Evaluation of OptiBP Under Investigational Use

Study Overview
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Brief Summary
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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
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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 through the camera of a smartphone on the tip of the index of the opposite arm.

Official Title
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Data Collection and Evaluation of a Mobile, Machine-learning-based Solution for Blood Pressure Estimation - the OptiBP Study.

Conditions
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General Population

Intervention / Treatment
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* Device: OptiBP Study app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Principal Arm<br>Each participant will use the OptiBP Study app on their smartphone | Device: OptiBP Study app<br>* Each participant will use OptiBP Study app to measure their blood pressure optically by applying their fingertip to their smartphone camera, and subsequently enter the blood pressure values obtained by measuring it with their own blood pressure cuff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models | To collect data to train a machine-learning based solution for estimating blood pressure. Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor at the upper arm, while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm. The performance of the machine learning model will be assessed by calculating the mean and standard deviation of the error of blood pressure estimations versus cuff-based, automatic, over-the-counter blood pressure monitors. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety by assessing inconvenience and adverse events | To identify potential use errors of an app that use the machine-learning model to estimate blood pressure. And to assess safety of the intervention. | 12 months |