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Comparing PPG-based Blood Pressure Measurement to the Gold Standard Manometer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03810586
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : July 9, 2019
Information provided by (Responsible Party):
Biobeat Technologies Ltd.

Brief Summary:
Continuous blood pressure (BP) measurement is in use today with an ambulatory, sphygmomanometer-based, device. This device, also called BP Holter, gives essential data for the clinician, allowing better hypertension (HTN) diagnosis and treatment. Alongside, the device has some substantial limitations preventing its use as a longer term BP monitoring allowing better HTN control. A new method of continuous BP monitoring, based on photo plethysmography (PPG), has been invented to ease patients' use and increase their responsiveness. This study aims to check whether the new, PPG-based method, of BP measurement can be as good as the current, gold standard, sphygmomanometer-based device.

Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure Disorders Device: Non-invasive measurement of blood pressure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Recruitment will be via printed advertisements distributed throughout the medical center. Volunteers will arrive on the morning of the test and fill a questionnaire about their demographics and every day activities. After completing the questionnaire, the participants will be connected to both devices, one on each arm and undergo a briefing about both devices. A first calibration measurement will take place followed by BP measurement every 20 minutes, and up to a 24 hour period. After 24 hours of measurements, the participants will return to Hadassah Medical Center and fill in another questionnaire, which will include feedback on the use of both devices.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Continuous Blood Pressure Measurement Using a Non-invasive Photo Plethysmography-based Monitor With the Gold Standard Sphygmomanometer-based Holter Monitor
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Comparing blood pressure measurement
In each volunteer, non-invasive measurements of blood pressure will be taken at the same time using a holter manometry device (HUGECARE NIBP Monitor) and the Biobeat BB-613 device, and compared, to show the accuracy and the comparability of the BB-613. As mentioned in the protocol, there would be no medical interventions within the scope of this study. In case hypertension will be observed in a volunteer, the volunteer will be advised by the investigators to see his physician for further evaluation.
Device: Non-invasive measurement of blood pressure
Comparing non-invasive measurement of blood pressure using the PPG-based BB-613 device to a blood pressure manomtry holter device (HUGECARE NIBP Monitor)

Primary Outcome Measures :
  1. Accurate and comparable blood pressure measurement by BB-613 [ Time Frame: 24 hours per participant ]
    Blood pressure measurements using the PPG-based BB-613 device will be taken and compared to blood pressure measurements taken at the same time using the holter device HUGECARE NIBP Monitor, with the aim of showing they are comparable

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Either healthy or chronically ill who are treated accordingly and with no need of any medical intervention during the study.

Exclusion Criteria:

  • A volunteer's refusal to enter the study.
  • Patients who are currently in hospitalization or in medical assessment.
  • Pregnant women and children under 18.
  • Volunteers with powerless jurisdiction.
  • Workers of the Hadassah Medical Center

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03810586

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Contact: Arik Eisenkraft, MD, MHA +972-52-9210896
Contact: Arik Ben-Ishay +972-53-5287768

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The Hadassah Ein Kerem Medical Center Recruiting
Jerusalem, Israel
Contact: Dean Nachman, MD    +972502217665   
Contact: Adi Gilan    +972543039545   
Sponsors and Collaborators
Biobeat Technologies Ltd.
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Principal Investigator: Dean Nachman, MD The Hadassah Ein Kerem Medical Center, Jerusalem

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Responsible Party: Biobeat Technologies Ltd. Identifier: NCT03810586     History of Changes
Other Study ID Numbers: Biobeat002
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Biobeat Technologies Ltd.:
Continuous Monitoring
Non-invasive Blood Pressure
Non-invasive Monitoring
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases