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NCT Number: NCT07240831

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

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.

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Key information

Conditions

Blood Pressure Blood Pressure Monitoring Cardiovascular Diseases Heart Disease Heart Diseases Hypertension Hypertension (HTN) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HaEmek Hospital, Afula, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Model BB-613WP

Device

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

Primary outcomes

  1. Primary Endpoint

    Time frame: 24 hours monitoring

    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.

Secondary outcomes

  1. Secondary Endpoint

    Time frame: 24 hours

    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).

  2. Secondary Endpoint

    Time frame: 24 hours

    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 monitoring

    Additional 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

Other outcomes

  1. Other Endpoints (exploratory analyses)

    Time frame: 24 hours

    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

  2. Other Endpoints (exploratory analyses)

    Time frame: 24 hours

    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

  3. Other Endpoints (exploratory analyses)

    Time frame: 24 hours

    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

  4. Other Endpoints (exploratory analyses)

    Time frame: 24 hours

    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

  5. Other Endpoints (exploratory analyses)

    Time frame: 24 hours

    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

  6. Other Endpoints (exploratory analyses)

    Time frame: 24 hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruth Caspi-Molad, M.S.c

CONTACT

[email protected]

+972546969474

Sponsors and collaborators

Lead sponsor

Biobeat Technologies Ltd.

Industry

Collaborators

  • Mayo Clinic

Registry information

Official study title

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

Acronym: PPG ABPM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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