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NOT YET RECRUITING
NCT07240831
NA

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

Sponsor: Biobeat Technologies Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-12-15

Completion Date

2026-10-30

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DEVICE

Model BB-613WP

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

Locations (2)

U Health

Miami, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States