Recruiting

Blood Pressure Monitoring

Sponsor:

Biobeat Technologies Ltd.

Code:

NCT07240831

Conditions

Blood Pressure

Heart Disease

Hypertension (HTN)

Blood Pressure Monitoring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Model BB-613WP

Study Details

Brief 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.

Conditions

Blood Pressure

Heart Disease

Hypertension (HTN)

Blood Pressure Monitoring

Study ID

NCT07240831

Start date

Dec 15, 2025

Status verified date

Aug, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Device: Non-invasive monitoring

The study is designed as a prospective, multicenter, single arm, validation study that follows the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices.27 There is no primary hypothesis. The study will validate 24-hours blood pressure monitoring using the investigational FDA-cleared device by comparing the level of agreement with parallel measurements obtained by the gold-standard upper arm. The Awake/Asleep test is the first and primary test recommended for this type of device to assess validity.

Interventions

Model BB-613WP

During the study period, participants will undergo standard ABPM monitoring per clinical indication and wear a PPG-based monitor

Primary outcome measure

  • Primary Endpoint [ Time Frame: 24 hours monitoring ]

Central Contacts and Locations

Central contacts

Ruth Caspi-Molad, M.S.c

+972546969474ruthie.caspi@bio-beat.com

Locations

Cardiology, P.C.

Recruiting

Birmingham, Alabama, United States, 35211

Contacts

Susan DeRamus, Clinical Research Director, RN, CCRC

205-949-5275sderamus@cardiologypc.com

Principal Investigator:

Ferrell O. Mendelsohn, MD

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Betty Monari, Associate Clinical Research Coordinator

480-574-2641Monari.Betty@mayo.edu

Desiree N. Osborne, Associate Clinical Research Coordinator

480-574-2234osborne.desiree@mayo.edu

Principal Investigator:

Sayeed Khalillullah, MD

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Umar Farooq, ACRC

farooq.muhammad@mayo.edu

Principal Investigator:

Lyle W. Baker, MD

U Health-University of Miami Health System

Recruiting

Miami, Florida, United States, 33136

Contacts

Bonni Lang, RN, BSN, MS, MBA

305-243-4950blang@med.miami.edu

Claudine Berthold

cxb1646@med.miami.edu

Principal Investigator:

Maria Delgado, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202-2689

Contacts

Renee Bess

313.343.4811rbess1@hfhs.org

Principal Investigator:

Amir Kaki, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Travis Nusbaum, Study Coordinator

507-538-6379nusbaum.travis@mayo.edu

Justin Webster, Associate Clinical Research Coordinator, B. S

Webster.Justin@mayo.edu

Principal Investigator:

Ziad Zoghby, MD, MBA

More Information

Sponsor

Biobeat Technologies Ltd.

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • BLOOD PRESSURE
  • BLOOD PRESSURE MONITORING
  • Hypertension (HTN)
  • CUFFLESS PHOTOPLETHYSMOGRAPHY
  • PPG
  • CUFFLESS
  • vital signs
  • ABPM
  • 24 hour ABPM
  • Ambulatory Blood Pressure Monitoring
  • Ambulatory Blood Pressure
  • BP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Biobeat Technologies Ltd. on 2026-08-13.