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.

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.

Study Overview

• Status: Recruiting
• Conditions: General Population
• Intervention / Treatment: Device: OptiBP Study app

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.

• Study Type: Interventional
• Enrollment (Estimated): 500000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederic Frappereau; Phone Number: 650-229-8604; Email: study@biospectal.com

Study Locations

• United States
  • California
    • Truckee, California, United States, 96161
      • Recruiting
      • Decentralized Trial
      • Contact: Frederic Frappereau; Phone Number: 650-229-8604; Email: study@biospectal.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Principal Arm; Each participant will use the OptiBP Study app on their smartphone	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biospectal
• Investigators: Principal Investigator: Frederic Frappereau, Biospectal

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: US Data Collection Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is anonymized and used for machine learning training

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No