Actively Recruiting
Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Led by Biobeat Technologies Ltd. · Updated on 2026-05-13
600
Participants Needed
10
Research Sites
45 weeks
Total Duration
On this page
Sponsors
B
Biobeat Technologies Ltd.
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females and males aged 18 years or older from all skin tones/colors
- Scheduled for ambulatory blood pressure monitoring (ABPM) for hypertension screening, evaluation, or management
- Able to use a smartphone app temporarily downloaded for the study or a device provided by the study sponsor
- Participants with atrial fibrillation or atrial flutter are eligible if standard cuff-based ABPM monitor can capture blood pressure at initialization
You will not qualify if you...
- ABPM indication is orthostatic hypotension or Postural Orthostatic Tachycardiac Syndrome
- Neurological, psychological, or other conditions impairing consent or participation
- Inability to reliably access the Internet via smartphone
- Unable to perform standard cuff-based ABPM
- Average difference between arms greater than 15 mmHg systolic or 10 mmHg diastolic during calibration
- Known allergy to adhesives or skin patches
- Solid dark tattoos on the chest area where the device is applied
- Unwilling to have chest hair shaved if needed
- Unwilling to comply with study instructions (avoid vigorous exercise and showering for 24 hours while wearing the device)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
Active, Not Recruiting
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Active, Not Recruiting
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
U Health-University of Miami Health System
Miami, Florida, United States, 33136
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
HaEmek Hospital
Afula, Israel, 1834111
Actively Recruiting
7
The Holy Family Hospital Nazareth
Nazareth, Israel, 1641100
Actively Recruiting
8
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
9
Maccabi Healthcare
Tel Aviv, Israel
Actively Recruiting
10
Instituto Auxologico Italiano
Milan, Italy
Not Yet Recruiting
Research Team
R
Ruth Caspi-Molad, M.S.c
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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