<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03810586</url>
  </required_header>
  <id_info>
    <org_study_id>Biobeat002</org_study_id>
    <nct_id>NCT03810586</nct_id>
  </id_info>
  <brief_title>Comparing PPG-based Blood Pressure Measurement to the Gold Standard Manometer</brief_title>
  <official_title>Comparison of Continuous Blood Pressure Measurement Using a Non-invasive Photo Plethysmography-based Monitor With the Gold Standard Sphygmomanometer-based Holter Monitor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biobeat Technologies Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biobeat Technologies Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Continuous blood pressure (BP) measurement is in use today with an ambulatory,&#xD;
      sphygmomanometer-based, device. This device, also called BP Holter, gives essential data for&#xD;
      the clinician, allowing better hypertension (HTN) diagnosis and treatment. Alongside, the&#xD;
      device has some substantial limitations preventing its use as a longer term BP monitoring&#xD;
      allowing better HTN control. A new method of continuous BP monitoring, based on photo&#xD;
      plethysmography (PPG), has been invented to ease patients' use and increase their&#xD;
      responsiveness. This study aims to check whether the new, PPG-based method, of BP measurement&#xD;
      can be as good as the current, gold standard, sphygmomanometer-based device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HTN is a major risk factor for cerebrovascular morbidity and mortality, yet its&#xD;
      identification can be delayed due to lack of overt symptoms, relying on BP measurements for&#xD;
      diagnosis. Several BP monitoring techniques are used in clinics and hospitals, and there is&#xD;
      also an outpatient method that is used for 24-hour BP monitoring, based on a&#xD;
      sphygmomanometer. The general notion is that by using tight BP monitoring in the clinic and&#xD;
      during the day, the health system will be able to diagnose hypertension among individuals at&#xD;
      an early stage, including high risk patients in the community.&#xD;
&#xD;
      Ambulatory BP monitoring for a period of 24 hours is considered to be better than&#xD;
      measurements taken in a clinic setting. First, 24 hours monitoring performed at home can help&#xD;
      confirm that hypertension actually does exist, thus ruling out the potential of &quot;white coat&#xD;
      syndrome&quot;. Second, measurements of BP during sleep also have a predictive value for&#xD;
      hypertension in high risk patients. Furthermore, ambulatory BP measurements are a stronger&#xD;
      predictor of all-cause and cardiovascular mortality than BP measurements in the clinic.&#xD;
      Finally, continuous BP monitoring is beneficial for controlling hypertension in diagnosed and&#xD;
      treated patients.&#xD;
&#xD;
      The gold standard ambulatory non-invasive BP monitor that is in broad use today is a&#xD;
      sphygmomanometer-based device that includes a cuff, which contracts around the patient's arm&#xD;
      and measures BP every 15 to 20 minutes. The cuff is usually uncomfortable for the patients&#xD;
      and could prevent them from doing their everyday activities. It can also disrupt the quality&#xD;
      of their sleep at night. For these reasons patients are sometimes reluctant to use it. A more&#xD;
      comfortable, user- friendly device, which allows a non-invasive, continuous BP measurement&#xD;
      will provide a simple, more efficient way for BP monitoring, and will potentially enable to&#xD;
      improve the outcome of medical treatment.&#xD;
&#xD;
      A new way for continuous non-invasive BP monitoring is based on the reflective photo&#xD;
      plethysmography (PPG) method. A company called &quot;Biobeat&quot; invented a device that measures PPG&#xD;
      wave in high temporal resolution that maintains more properties and markings of the original&#xD;
      pulse wave than usual PPG-based devices, thereby enabling to provide data on several&#xD;
      physiological parameters other than Heart Rate (HR) and blood oxygen saturation, such as:&#xD;
      Systolic Blood Pressure (SBP) and its variation, Diastolic Blood Pressure (DBP) and its&#xD;
      variation, Pulse Pressure and more. This device can also send and surveillance. The Biobeat&#xD;
      device (BB-613) includes either a wearable watch or a patch with a sticker that the patient&#xD;
      puts on his/her body. This device may increase the patient's willingness to use it and can&#xD;
      also make the measurement more reliable (explanation on the PPG-based sensor and the device&#xD;
      itself are provided in the appendixes).&#xD;
&#xD;
      The measurements are transferred via Wi-Fi to the patient's doctor and allows close&#xD;
      monitoring.&#xD;
&#xD;
      The purpose of the study The study's main purpose is to compare continuous 24-hour BP&#xD;
      measurement using the non-invasive PPG-based BB-613 device with one of the gold standard&#xD;
      sphygmomanometer-based devices that is currently-used throughout the Israeli health system&#xD;
      (HUGECARE NIBP Monitor). As accepted according to the AAMI (Association for the Advancement&#xD;
      of Medical Instrumentation) and the European Hypertension Society, the parameters that are&#xD;
      investigated in this study will be systolic BP, diastolic BP and the average between them&#xD;
      (MAP).&#xD;
&#xD;
      The use of the PPG sensor for BP measurement will be considered as successful if there will&#xD;
      be correlation of at least 5/10/15 mmHg between the measurements of both the PPG sensor and&#xD;
      the sphygmomanometer-based Holter. The difference between measurements of the PPG and&#xD;
      manometer devices will be less than 5 mmHg in at least 75% of the measurements, less than 10&#xD;
      mmHg in at least 90% of the measurements and less than 15 mmHg in at least 96% of the&#xD;
      measurements. The results will fulfil at least two of these criteria.&#xD;
&#xD;
      In addition to the BP measurement comparison, in this study the investigators will also&#xD;
      compare the degree of comfort and accessibility for participants between the Bio Beat device&#xD;
      and the gold standard Holter device that is currently in use.&#xD;
&#xD;
      Study hypothesis The study's hypothesis is that the PPG-based sensor will give reliable&#xD;
      results of continuous BP monitoring in a comfortable and user-friendly way. In addition, the&#xD;
      accuracy of the sensor will not be inferior to the Holter that is now in use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">June 25, 2020</completion_date>
  <primary_completion_date type="Actual">April 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accurate and comparable blood pressure measurement by BB-613</measure>
    <time_frame>24 hours per participant</time_frame>
    <description>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</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Hypertension</condition>
  <condition>Blood Pressure Disorders</condition>
  <arm_group>
    <arm_group_label>Comparing blood pressure measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-invasive measurement of blood pressure</intervention_name>
    <description>Comparing non-invasive measurement of blood pressure using the PPG-based BB-613 device to a blood pressure manomtry holter device (HUGECARE NIBP Monitor)</description>
    <arm_group_label>Comparing blood pressure measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Either healthy or chronically ill who are treated accordingly and with no need of any&#xD;
             medical intervention during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A volunteer's refusal to enter the study.&#xD;
&#xD;
          -  Patients who are currently in hospitalization or in medical assessment.&#xD;
&#xD;
          -  Pregnant women and children under 18.&#xD;
&#xD;
          -  Volunteers with powerless jurisdiction.&#xD;
&#xD;
          -  Workers of the Hadassah Medical Center&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dean Nachman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hadassah Ein Kerem Medical Center, Jerusalem</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hadassah Ein Kerem Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Continuous Monitoring</keyword>
  <keyword>Non-invasive Blood Pressure</keyword>
  <keyword>Non-invasive Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810586
org study id: Biobeat002
nct id: NCT03810586
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
HTN is a major risk factor for cerebrovascular morbidity and mortality, yet its
      identification can be delayed due to lack of overt symptoms, relying on BP measurements for
      diagnosis. Several BP monitoring techniques are used in clinics and hospitals, and there is
      also an outpatient method that is used for 24-hour BP monitoring, based on a
      sphygmomanometer. The general notion is that by using tight BP monitoring in the clinic and
      during the day, the health system will be able to diagnose hypertension among individuals at
      an early stage, including high risk patients in the community.

      Ambulatory BP monitoring for a period of 24 hours is considered to be better than
      measurements taken in a clinic setting. First, 24 hours monitoring performed at home can help
      confirm that hypertension actually does exist, thus ruling out the potential of "white coat
      syndrome". Second, measurements of BP during sleep also have a predictive value for
      hypertension in high risk patients. Furthermore, ambulatory BP measurements are a stronger
      predictor of all-cause and cardiovascular mortality than BP measurements in the clinic.
      Finally, continuous BP monitoring is beneficial for controlling hypertension in diagnosed and
      treated patients.

      The gold standard ambulatory non-invasive BP monitor that is in broad use today is a
      sphygmomanometer-based device that includes a cuff, which contracts around the patient's arm
      and measures BP every 15 to 20 minutes. The cuff is usually uncomfortable for the patients
      and could prevent them from doing their everyday activities. It can also disrupt the quality
      of their sleep at night. For these reasons patients are sometimes reluctant to use it. A more
      comfortable, user- friendly device, which allows a non-invasive, continuous BP measurement
      will provide a simple, more efficient way for BP monitoring, and will potentially enable to
      improve the outcome of medical treatment.

      A new way for continuous non-invasive BP monitoring is based on the reflective photo
      plethysmography (PPG) method. A company called "Biobeat" invented a device that measures PPG
      wave in high temporal resolution that maintains more properties and markings of the original
      pulse wave than usual PPG-based devices, thereby enabling to provide data on several
      physiological parameters other than Heart Rate (HR) and blood oxygen saturation, such as:
      Systolic Blood Pressure (SBP) and its variation, Diastolic Blood Pressure (DBP) and its
      variation, Pulse Pressure and more. This device can also send and surveillance. The Biobeat
      device (BB-613) includes either a wearable watch or a patch with a sticker that the patient
      puts on his/her body. This device may increase the patient's willingness to use it and can
      also make the measurement more reliable (explanation on the PPG-based sensor and the device
      itself are provided in the appendixes).

      The measurements are transferred via Wi-Fi to the patient's doctor and allows close
      monitoring.

      The purpose of the study The study's main purpose is to compare continuous 24-hour BP
      measurement using the non-invasive PPG-based BB-613 device with one of the gold standard
      sphygmomanometer-based devices that is currently-used throughout the Israeli health system
      (HUGECARE NIBP Monitor). As accepted according to the AAMI (Association for the Advancement
      of Medical Instrumentation) and the European Hypertension Society, the parameters that are
      investigated in this study will be systolic BP, diastolic BP and the average between them
      (MAP).

      The use of the PPG sensor for BP measurement will be considered as successful if there will
      be correlation of at least 5/10/15 mmHg between the measurements of both the PPG sensor and
      the sphygmomanometer-based Holter. The difference between measurements of the PPG and
      manometer devices will be less than 5 mmHg in at least 75% of the measurements, less than 10
      mmHg in at least 90% of the measurements and less than 15 mmHg in at least 96% of the
      measurements. The results will fulfil at least two of these criteria.

      In addition to the BP measurement comparison, in this study the investigators will also
      compare the degree of comfort and accessibility for participants between the Bio Beat device
      and the gold standard Holter device that is currently in use.

      Study hypothesis The study's hypothesis is that the PPG-based sensor will give reliable
      results of continuous BP monitoring in a comfortable and user-friendly way. In addition, the
      accuracy of the sensor will not be inferior to the Holter that is now in use.
allocation: N/A
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.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accurate and comparable blood pressure measurement by BB-613
time frame: 24 hours per participant
description: 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
arm group label: Comparing blood pressure measurement
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: Non-invasive measurement of blood pressure
description: Comparing non-invasive measurement of blood pressure using the PPG-based BB-613 device to a blood pressure manomtry holter device (HUGECARE NIBP Monitor)
arm group label: Comparing blood pressure measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dean Nachman, MD
role: Principal Investigator
affiliation: The Hadassah Ein Kerem Medical Center, Jerusalem
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Undecided