Data Collection and Evaluation of OptiBP Under Investigational Use

Purpose

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.

Condition

  • General Population

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico); 2. Live in the United States of America 3. Have an Android smartphone 4. Have access to an arm-worn blood pressure monitor (cuff) 5. Have access to the Google Play store to download the OptiBP study app on their phone 6. Be comfortable communicating in written and spoken English 7. Be willing and able to provide informed consent to participate in the study

Exclusion Criteria

  1. Known contact dermatitis to nickel/chromium 2. Lesion or deficiency on hand, preventing placing a finger on the smartphone camera 3. Known dysrhythmia like bigeminy, trigeminy, isolated VPB, atrial fibrillation

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Principal Arm
Each participant will use the OptiBP Study app on their smartphone
  • Device: OptiBP Study app
    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.

Recruiting Locations

Decentralized Trial
Truckee, California 96161
Contact:
Frederic Frappereau
650-229-8604
study@biospectal.com

More Details

Status
Recruiting
Sponsor
Biospectal

Study Contact

Frederic Frappereau
650-229-8604
study@biospectal.com

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 through the camera of a smartphone on the tip of the index of the opposite arm.