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

What this Trial Is About

Researchers are evaluating the accuracy and reliability of a cuffless photoplethysmography (PPG) chest-patch device for 24-hour blood pressure monitoring compared to the standard ambulatory blood pressure monitoring (ABPM) using an upper arm cuff. This study follows the 2023 European Society of Hypertension (ESH) guidelines and includes adults referred for 24-hour ABPM for clinical reasons, including both hypertensive and normotensive individuals. The primary focus is on the Awake/Asleep test recommended for wearable cuffless BP devices. Participants will wear both the investigational Biobeat PPG-based chest patch and the standard cuff-based ABPM device simultaneously for 24 hours. The single-use, wireless patch continuously measures blood pressure and other vital signs via PPG technology and is calibrated with three cuff measurements at the start. The study is a prospective, multicenter, single-arm validation comparing measurements during awake, asleep, and total 24-hour periods to assess agreement between devices. During the study, participants will be monitored for blood pressure readings, device comfort, and usability. Data comparisons will focus on accuracy defined by mean difference and standard deviation thresholds. Researchers will also assess performance across blood pressure ranges and demographic groups. Safety monitoring includes observation for mild skin irritation from the adhesive patch. Total participation involves wearing both devices for a 24-hour period, followed by data analysis.

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