Recruiting

OptiBP

Sponsor:

Biospectal

Code:

NCT06017687

Conditions

General Population

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

OptiBP Study app

Study Details

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.

Conditions

General Population

Study ID

NCT06017687

Start date

Sep 28, 2023

Status verified date

Sep, 2023

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

500000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Principal Arm

Each participant will use the OptiBP Study app on their smartphone

Interventions

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.

Primary outcome measure

  • Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Frederic Frappereau

650-229-8604study@biospectal.com

Locations

Decentralized Trial

Recruiting

Truckee, California, United States, 96161

Contacts

Frederic Frappereau

650-229-8604study@biospectal.com

More Information

Sponsor

Biospectal

Last update posted

Sep 29, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Biospectal on 2023-09-29.