Data Collection and Evaluation of OptiBP Under Investigational Use

General Population Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017687
• Other study ID #: US Data Collection Study
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: September 2026

Study information

• Verified date: September 2023
• Source: Biospectal
• Contact: Frederic Frappereau
• Phone: 650-229-8604
• Email: study[@]biospectal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500000
• Est. completion date: September 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Population

Intervention

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.

Locations

Country	Name	City	State
United States	Decentralized Trial	Truckee	California

Sponsors (1)

Lead Sponsor	Collaborator
Biospectal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models	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.	12 months
Secondary	Safety by assessing inconvenience and adverse events	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.	12 months