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

NCT07240831 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-13

No results posted yet for this study

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

Interventions

DEVICE

Model BB-613WP

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

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Biobeat Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Ziad Zoghby, M.D., M.B.A. · Mayo Clinic College of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-10-30
Completion
2026-10-30
FDA Device
Yes

Countries

  • United States
  • Israel
  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07240831 on ClinicalTrials.gov