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NCT Number: NCT06017687

Data Collection and Evaluation of OptiBP Under Investigational Use

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.

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Key information

Conditions

General Population

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Decentralized Trial

Truckee, California, 96161, United States

Location status: Recruiting

Location contact

Frederic Frappereau

CONTACT

[email protected]

650-229-8604

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OptiBP Study app

Device

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 outcomes

  1. Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models

    Time frame: 12 months

    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.

Secondary outcomes

  1. Safety by assessing inconvenience and adverse events

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frederic Frappereau

CONTACT

[email protected]

650-229-8604

Sponsors and collaborators

Lead sponsor

Biospectal

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Aug 30, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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