NCT07240831

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Biobeat Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to evaluate the accuracy, validity, and efficacy of the Biobeat PPG-based cuffless chest-worn monitor for continuous and ambulatory blood pressure monitoring compared with a standard cuff-based ambulatory blood pressure monitor (ABPM). The study will follow the 2023 European Society of Hypertension (ESH) protocol for validating cuffless BP devices. The Biobeat device is a single-use, wireless, noninvasive patch applied to the chest that continuously measures blood pressure and other vital signs using photoplethysmography (PPG) technology. The trial is a prospective, multicenter, single-arm validation study in adults undergoing 24-hour ABPM for any clinical indication. Participants will simultaneously wear both the Biobeat device and a standard ABPM for 24 hours. The Biobeat device will be calibrated with three reference cuff measurements at the start of monitoring. Data from both devices will be compared across awake, asleep, and total 24-hour periods to determine agreement in systolic and diastolic blood pressure. The primary objective is to demonstrate equivalence between the Biobeat PPG-based system and standard ABPM, with accuracy defined as a mean difference ≤5 mmHg and standard deviation ≤8 mmHg. Secondary endpoints include assessment of device performance across different blood pressure ranges and demographic subgroups, as well as participant comfort and usability. The study represents minimal risk to participants; the only potential adverse effect is mild skin irritation from the adhesive patch. Successful validation will confirm that the Biobeat cuffless PPG-based device provides accurate, reliable 24-hour blood pressure monitoring comparable to existing ABPM systems, supporting its use as a comfortable, patient-friendly alternative for both clinical and ambulatory settings.

Conditions

• Blood Pressure
• Heart Disease
• Hypertension (HTN)
• Blood Pressure Monitoring

Interventions

Type	Name	Description
DEVICE	Model BB-613WP	During the study period, participants will undergo standard ABPM monitoring per clinical indication and wear a PPG-based monitor

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study