NCT06017687

Data Collection and Evaluation of OptiBP Under Investigational Use

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500,000 (estimated)
• Sponsor: Biospectal · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• General Population

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-28
• Primary completion: 2024-09-01
• Completion: 2026-09-01
• First posted: 2023-08-30
• Last updated: 2023-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study