Data Collection and Evaluation of OptiBP Under Investigational Use

NCT06017687 | Recruiting FDA Device

• 1 other identifier: US Data Collection Study
• Study Type: interventional
• Target: 500,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety by assessing inconvenience and adverse events

  12 months

Study Arms (1)

Principal Arm

OTHER

Each participant will use the OptiBP Study app on their smartphone

Device: OptiBP Study app

Interventions

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.

Principal Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biospectal: lead

Study Sites (1)

Decentralized Trial

Truckee, California, 96161, United States

RECRUITING

Study Officials

• Frederic Frappereau

  Biospectal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic Frappereau

CONTACT

650-229-8604; study@biospectal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: September 28, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)