RecruitingNot ApplicableNCT07240831

Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring


Sponsor

Biobeat Technologies Ltd.

Enrollment

600 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Model BB-613WP for people with blood pressure, blood pressure monitoring, and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEModel BB-613WP

During the study period, participants will undergo standard ABPM monitoring per clinical indication and wear a PPG-based monitor


Locations(11)

Cardiology, P.C.

Birmingham, Alabama, United States

Mayo Clinic

Scottsdale, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

U Health-University of Miami Health System

Miami, Florida, United States

Henry Ford Health System

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

HaEmek Hospital

Afula, Israel

The Holy Family Hospital Nazareth

Nazareth, Israel

Sheba Medical Center

Ramat Gan, Israel

Maccabi Healthcare

Tel Aviv, Israel

Instituto Auxologico Italiano

Milan, Italy

View Full Details on ClinicalTrials.gov

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NCT07240831


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