Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Biobeat Technologies Ltd.
Study ID
NCT07240831
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Jun 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
600 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

Primary Endpoint [ Time Frame: 24 hours monitoring ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Cardiology, P.C.BirminghamAlabama35211
Susan DeRamus, Clinical Research Director, RN, CCRC
[email protected]
205-949-5275
Ferrell O. Mendelsohn, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicScottsdaleArizona85259
Betty Monari, Associate Clinical Research Coordinator
[email protected]
480-574-2641
Desiree N. Osborne, Associate Clinical Research Coordinator
[email protected]
480-574-2234
Sayeed Khalillullah, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicJacksonvilleFlorida32224
Umar Farooq, ACRC
[email protected]
Lyle W. Baker, MD (PRINCIPAL_INVESTIGATOR)
U Health-University of Miami Health SystemMiamiFlorida33136
Bonni Lang, RN, BSN, MS, MBA
[email protected]
305-243-4950
Claudine Berthold
[email protected]
Maria Delgado, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Travis Nusbaum, Study Coordinator
[email protected]
507-538-6379
Justin Webster, Associate Clinical Research Coordinator, B. S
[email protected]
Ziad Zoghby, MD, MBA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
Cardiology, P.C.· Birmingham, ALMayo Clinic· Scottsdale, AZMayo Clinic· Jacksonville, FLU Health-University of Miami Health System· Miami, FLMayo Clinic· Rochester, MN

Related Studies