<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/NCT03771794</url>
  </required_header>
  <id_info>
    <org_study_id>0024-18-HYMC</org_study_id>
    <nct_id>NCT03771794</nct_id>
  </id_info>
  <brief_title>Heart Rate Variability Augmentation With RR2 Neuromodulation Device</brief_title>
  <official_title>Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Brief Summary: A randomized double-blinded, sham-controlled, crossover study&#xD;
&#xD;
      Condition or Disease: impaired autonomic balance measured by heart rate variability&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized double-blinded, sham-controlled, crossover study&#xD;
&#xD;
      Condition or Disease: impaired autonomic balance measured by heart rate variability&#xD;
&#xD;
      Intervention/treatment:&#xD;
&#xD;
      Device: ReguRate RR2 neurostimulation system Device: Sham ReguRate RR2 neurostimulation&#xD;
      system&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      Study Type: Interventional (clinical trial) Planned enrollment: 60 participants Allocation:&#xD;
      Randomized Intervention Model; Cross Over Masking: Double (participant, Investigator) Primary&#xD;
      Purpose: Treatment Official Title: Non-Invasive peripheral neuromodulation to augment HRV in&#xD;
      healthy adults&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">December 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Active Comparator: ReguRate RR2 active. Device: ReguRate neurostimulation system&#xD;
Sham Comparator: ReguRate RR2 placebo. Device: Sham ReguRate electrical stimulation - mock sham stimulation mode</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with 15% or HRV change immediately after neurostimulation session</measure>
    <time_frame>1 week</time_frame>
    <description>HRV augmentation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in heart rate</measure>
    <time_frame>1 week</time_frame>
    <description>Percentage of patients with 5% or more decrease in heart rate</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of patients with 5% or more decrease in blood pressure</measure>
    <time_frame>1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of patients with change in additional HRV parameters (rMSSD, LF,HF,L/HF)</measure>
    <time_frame>1 week</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Active Comparator: ReguRate RR2 active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: ReguRate neurostimulation device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Comparator: ReguRate RR2 sham.</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Device: Sham ReguRate neurostimulation - mock sham stimulation mode</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ReguRate neurostimulation</intervention_name>
    <description>Device: ReguRate neurostimulation Device:&#xD;
Sham : ReguRate neurostimulation - mock sham stimulation mode</description>
    <arm_group_label>Active Comparator: ReguRate RR2 active</arm_group_label>
    <arm_group_label>Sham Comparator: ReguRate RR2 sham.</arm_group_label>
    <other_name>Sham ReguRate neurostimulation - mock sham stimulation mode</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Inclusion criteria :&#xD;
&#xD;
          1. Healthy male and female volunteers ages 25-60&#xD;
&#xD;
          2. 2 minute HRV measurement with SDNN&lt;35 ms (below 35 ms)&#xD;
&#xD;
          3. Participants able and willing to comply with the study protocol&#xD;
&#xD;
          4. Participants able and willing to sign a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          1. Participant with a known cardiovascular disease&#xD;
&#xD;
          2. Participants with COPD&#xD;
&#xD;
          3. Participants with any known history of epilepsy&#xD;
&#xD;
          4. Participants with detected arrhythmia on test day&#xD;
&#xD;
          5. Participants with implanted electrical and/or neurostimulation device (such as cardiac&#xD;
             pace maker/defibrillator/VNS stimulator/SNS stimulator/occipital nerve stimulator/deep&#xD;
             brain stimulator etc.)&#xD;
&#xD;
          6. Heavy smokers (more than 1 package of cigarets a day)&#xD;
&#xD;
          7. Participants with a plan to change medications&#xD;
&#xD;
          8. History of vasovagal syncope&#xD;
&#xD;
          9. Pregnancy or bleeding&#xD;
&#xD;
         10. Participants enrolled in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sharon Tsuk, PHD</last_name>
    <phone>972-9-8639368</phone>
    <email>sharontsuk1@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wingate Institute</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharon Tsuk, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Raffael Carasso, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sharon Tsuk, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wingate Institute</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharon</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hillel Yaffe Medical Center</investigator_affiliation>
    <investigator_full_name>Prof. Ahud Sternberg</investigator_full_name>
    <investigator_title>Chairman of Helsinki Ethics Committee</investigator_title>
  </responsible_party>
  <keyword>HRV</keyword>
  <keyword>Peripheral neuromodulation</keyword>
  <keyword>Autonomic balance</keyword>
  <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/NCT03771794
org study id: 0024-18-HYMC
nct id: NCT03771794
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Brief Summary: A randomized double-blinded, sham-controlled, crossover study

      Condition or Disease: impaired autonomic balance measured by heart rate variability
A randomized double-blinded, sham-controlled, crossover study

      Condition or Disease: impaired autonomic balance measured by heart rate variability

      Intervention/treatment:

      Device: ReguRate RR2 neurostimulation system Device: Sham ReguRate RR2 neurostimulation
      system

      Study Design:

      Study Type: Interventional (clinical trial) Planned enrollment: 60 participants Allocation:
      Randomized Intervention Model; Cross Over Masking: Double (participant, Investigator) Primary
      Purpose: Treatment Official Title: Non-Invasive peripheral neuromodulation to augment HRV in
      healthy adults
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Active Comparator: ReguRate RR2 active. Device: ReguRate neurostimulation system
Sham Comparator: ReguRate RR2 placebo. Device: Sham ReguRate electrical stimulation - mock sham stimulation mode
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of patients with 15% or HRV change immediately after neurostimulation session
time frame: 1 week
description: HRV augmentation
measure: Decrease in heart rate
time frame: 1 week
description: Percentage of patients with 5% or more decrease in heart rate
measure: Percentage of patients with 5% or more decrease in blood pressure
time frame: 1 week
measure: Percentage of patients with change in additional HRV parameters (rMSSD, LF,HF,L/HF)
time frame: 1 week
arm group label: Active Comparator: ReguRate RR2 active
arm group type: Active Comparator
description: Device: ReguRate neurostimulation device
arm group label: Sham Comparator: ReguRate RR2 sham.
arm group type: Sham Comparator
description: Device: Sham ReguRate neurostimulation - mock sham stimulation mode
intervention type: Device
intervention name: ReguRate neurostimulation
description: Device: ReguRate neurostimulation Device:
Sham : ReguRate neurostimulation - mock sham stimulation mode
arm group label: Active Comparator: ReguRate RR2 active
arm group label: Sham Comparator: ReguRate RR2 sham.
other name: Sham ReguRate neurostimulation - mock sham stimulation mode
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon Tsuk, PHD
phone: 972-9-8639368
email: sharontsuk1@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Hillel Yaffe Medical Center
investigator full name: Prof. Ahud Sternberg
investigator title: Chairman of Helsinki Ethics Committee
sharing ipd: Undecided