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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; Heart Disease; Hypertension (HTN); Blood Pressure Monitoring
• Intervention / Treatment: Device: Model BB-613WP

Detailed Description

This study aims to evaluate the accuracy, validity, and efficacy of the Biobeat PPG-based cuffless chest-worn monitor for continuous and ambulatory blood pressure monitoring compared with a standard cuff-based ambulatory blood pressure monitor (ABPM). The study will follow the 2023 European Society of Hypertension (ESH) protocol for validating cuffless BP devices. The Biobeat device is a single-use, wireless, noninvasive patch applied to the chest that continuously measures blood pressure and other vital signs using photoplethysmography (PPG) technology.

The trial is a prospective, multicenter, single-arm validation study in adults undergoing 24-hour ABPM for any clinical indication. Participants will simultaneously wear both the Biobeat device and a standard ABPM for 24 hours. The Biobeat device will be calibrated with three reference cuff measurements at the start of monitoring. Data from both devices will be compared across awake, asleep, and total 24-hour periods to determine agreement in systolic and diastolic blood pressure.

The primary objective is to demonstrate equivalence between the Biobeat PPG-based system and standard ABPM, with accuracy defined as a mean difference ≤5 mmHg and standard deviation ≤8 mmHg. Secondary endpoints include assessment of device performance across different blood pressure ranges and demographic subgroups, as well as participant comfort and usability. The study represents minimal risk to participants; the only potential adverse effect is mild skin irritation from the adhesive patch.

Successful validation will confirm that the Biobeat cuffless PPG-based device provides accurate, reliable 24-hour blood pressure monitoring comparable to existing ABPM systems, supporting its use as a comfortable, patient-friendly alternative for both clinical and ambulatory settings.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruth Caspi-Molad, M.S.c; Phone Number: +972546969474; Email: ruthie.caspi@bio-beat.com

Study Locations

• Israel
  • Afula, Israel, 1834111
    • Recruiting
    • HaEmek Hospital
    • Contact: Kerstin Carlin Ram, Research Coordinator
    • Principal Investigator: Lee Goldsetin Goldsetin, MD
  • Nazareth, Israel, 1641100
    • Recruiting
    • The Holy Family Hospital Nazareth
    • Contact: Diala Najjar, Research Coordinator
    • Principal Investigator: Nayef Habashi, MD
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Irena Tahel Cahana, Research Coordinator
    • Principal Investigator: Pazit Beckerman, MD
  • Tel Aviv, Israel
    • Recruiting
    • Maccabi Healthcare
    • Contact: Ella Goldberg, Research Coordinator
    • Principal Investigator: Galit Perez
• Italy
  • Milan, Italy
    • Not yet recruiting
    • Instituto Auxologico Italiano
    • Principal Investigator: Prof. Gianfranco Parati Parati, MD
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Active, not recruiting
      • Cardiology, P.C.
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Active, not recruiting
      • Mayo Clinic
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Contact: Umar Farooq, ACRC; Email: farooq.muhammad@mayo.edu
      • Principal Investigator: Lyle W. Baker, MD
    • Miami, Florida, United States, 33136
      • Recruiting
      • U Health-University of Miami Health System
      • Contact: Bonni Lang, RN, BSN, MS, MBA; Phone Number: 305-243-4950; Email: blang@med.miami.edu
      • Contact: Claudine Berthold; Email: cxb1646@med.miami.edu
      • Principal Investigator: Maria Delgado, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Justin Webster, Associate Clinical Research Coordinator, B. S; Email: Webster.Justin@mayo.edu
      • Principal Investigator: Ziad Zoghby, MD, MBA
      • Contact: Travis Nusbaum, Study Coordinator; Phone Number: 507-538-6379; Email: nusbaum.travis@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: Model BB-613WP; During the study period, participants will undergo standard ABPM monitoring per clinical indication and wear a PPG-based monitor; Other Names: Biobeat Chest-Patch, PPg-based monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	The accuracy and reliability of the PPG-based chest-patch device will be evaluated by comparing its blood pressure measurements with those obtained through the gold-standard upper arm cuff oscillometric ABPM method. Both systolic and diastolic blood pressure values will be assessed.	24 hours monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	Comparison of the compliance and completeness of the 2 measurement methods. The investigators will report the percentage of participants with at least 30% missed data (defining non-compliance or incomplete study).	24 hours
Secondary Endpoint	Convenience of the device (participants' questionnaire) will be assessed. Participants will rate the experience on a scale of 1 to 5, with 5 indicating a higher satisfaction score for the following questions: Comfort level during placement of the monitor; Comfort level during monitoring; Interference with sleep; Interference with daytime activity (i.e., dressing, ambulating, eating); General satisfaction with the monitoringAdditional questions-; Which diagnostic option would you recommend to a friend / family member? Options- Biobeat, cuff, either is fine. Answering "Biobeat" will be considered a positive response.; In the future, if you undergo monitoring with Biobeat- how would you prefer to receive the monitor? Options- Mailed directly home, applied at the clinic. Either response is acceptable	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Endpoints (exploratory analyses)	Subgroup analysis based on sex: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed	24 hours
Other Endpoints (exploratory analyses)	Subgroup analysis based on skin tone: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed	24 hours
Other Endpoints (exploratory analyses)	Subgroup analysis based on hypertension diagnosis (positive or negative) diagnosed by standard arm-based oscillometric ABPM: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed	24 hours
Other Endpoints (exploratory analyses)	Subgroup analysis based on participants with atrial fibrillation/atrial flutter: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed	24 hours
Other Endpoints (exploratory analyses)	Subgroup analysis based on participants with pacemaker: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed	24 hours
Other Endpoints (exploratory analyses)	Subgroup analysis based on day vs. night analysis: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed.	24 hours

Collaborators and Investigators

• Sponsor: Biobeat Technologies Ltd.
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Ziad Zoghby, M.D., M.B.A., Mayo Clinic College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension (HTN); vital signs; PPG; BLOOD PRESSURE; BLOOD PRESSURE MONITORING; CUFFLESS PHOTOPLETHYSMOGRAPHY; CUFFLESS
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Heart Diseases
• Other Study ID Numbers: Biobeat_CLP_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is proprietary company information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No