NCT07240831Completed
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 612 (actual)
- First submitted
- 24 Sept 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 2 Sept 2026
- Lead sponsor
- Biobeat Technologies Ltd.
- Diseases
- High blood pressure
- NCT number
- NCT07240831
What you commit to
- Study type: Interventional
- Participants enrolled: 612
- From 15 Dec 2025 to the primary completion date, 2 Sept 2026
- 11 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Indication for ABPM is orthostatic hypotension or Postural Orthostatic Tachycardiac Syndrome as indicated on the ABPM referral order
- Any neurological, psychological, or other condition impairing the ability to provide informed consent or participate in the study
- Subjects with known allergy to adhesives or skin patches
Other
- Inability to reliably access the Internet via a smart phone
- Not able to perform standard cuff-based ABPM
- Average absolute difference between the two arms is greater than 15 mmHg for Systolic Blood Pressure (SBP) or greater than 10 mmHg Diastolic Blood Pressure (DBP) during the initialization/calibration phase
- Subjects with solid dark tattoos on the area where the PPG-based device is attached
- Subjects who are unwilling to have their chest hair shaved, if needed, to install the device (the device uses adhesives and needs to be in direct contact with the skin without hair)
- Subjects who are unwilling to comply with the study instructions (avoid vigorous exercise and showering for 24 hours while the device is in place)
Who the study is looking for
- Females and Males subjects 18 years or older (from all skin tones/colors)
- Scheduled for ABPM for hypertension screening, evaluation, or management
- Subjects capable of using an application temporarily downloaded (for the duration of the study) on a personal smart phone device or on a device provided by the study sponsor
- Subjects with Atrial fibrillation or Atrial flutter are eligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HaEmek Hospital Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| The Holy Family Hospital Nazareth Coordinator of this site? Confirm its status | Nazareth | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Maccabi Healthcare Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Instituto Auxologico Italiano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Cardiology, P.C. Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| U Health-University of Miami Health System Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.