Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Recruiting · NCT07240831 · Interventional (participants receive a specific treatment) · Lead sponsor: Biobeat Technologies Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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 known allergy to adhesives or skin patches
- 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)
Where it is running
11 locations listed across 5 US states.
- Cardiology, P.C. - Birmingham, Alabama, United States
- Mayo Clinic - Scottsdale, Arizona, United States
- Mayo Clinic - Jacksonville, Florida, United States
- U Health-University of Miami Health System - Miami, Florida, United States
- Henry Ford Health System - Detroit, Michigan, United States
- Mayo Clinic - Rochester, Minnesota, United States
- HaEmek Hospital - Afula, Israel
- Instituto Auxologico Italiano - Milan, Italy
- The Holy Family Hospital Nazareth - Nazareth, Israel
- Sheba Medical Center - Ramat Gan, Israel
- Maccabi Healthcare - Tel Aviv, Israel