Data Collection and Evaluation of OptiBP Under Investigational Use

Biospectal

Status: Enrolling

Conditions: General Population

Treatments: Device: OptiBP Study app

Study type: Interventional

Funder types: Industry

Identifiers

NCT06017687

US Data Collection Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500,000 participants in 1 patient group

Principal Arm

Other group

Description:

Each participant will use the OptiBP Study app on their smartphone

Treatment:

Device: OptiBP Study app