Evaluating a Cuffless Photoplethysmography Chest-Patch Monitor Compared to Standard 24-Hour Ambulatory Blood Pressure Monitoring

What this Trial Is About

Researchers are evaluating a new cuffless photoplethysmography PPG chest-patch monitor to measure 24-hour blood pressure continuously. The study aims to validate the accuracy and reliability of this PPG-based device compared to the standard ambulatory blood pressure monitoring ABPM method using an upper arm cuff. The trial follows the 2023 European Society of Hypertension ESH guidelines, focusing on both hypertensive and normotensive adults referred for clinical ABPM. Participants will wear the Biobeat PPG-based chest patch and a standard cuff-based ABPM device simultaneously for 24 hours. The PPG device is a single-use, wireless, noninvasive patch applied to the chest, calibrated with three reference cuff measurements at the start. Blood pressure readings from both devices will be compared during awake, asleep, and total 24-hour periods. The study also assesses device comfort and usability as secondary goals. During the study, participants will be monitored for blood pressure accuracy and device performance, while avoiding vigorous exercise and showering for 24 hours. Researchers will collect data from both devices and evaluate agreement in systolic and diastolic pressures. Safety is monitored for mild skin irritation from the patch. The total participation involves wearing both devices for one day while following study instructions.

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