<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/NCT03000842</url>
  </required_header>
  <id_info>
    <org_study_id>5260/16</org_study_id>
    <nct_id>NCT03000842</nct_id>
  </id_info>
  <brief_title>Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters</brief_title>
  <official_title>Effects of Transcutaneous Vagal Nerve Stimulation (tVNS) on Blood Pressure, Heart Rate and Autonomic Control in Hypertensive Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Cardiologia do Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Cardiologia do Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic&#xD;
      regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was&#xD;
      developing a non-invasive device that is able to stimulate the auricular branch of vagal&#xD;
      nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct&#xD;
      stimulation of the vagal nerve. However, there are still no strong evidences about it actions&#xD;
      regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on&#xD;
      heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at&#xD;
      rest and after orthostatic position&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Autonomic control response to transcutaneous vagal nerve stimulation</measure>
    <time_frame>40 minutes</time_frame>
    <description>sympathetic and parasympathetic response to non-invasive vagal nerve stimulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure changes to transcutaneous vagal nerve stimulation</measure>
    <time_frame>40 minutes</time_frame>
    <description>systemic response to non-invasive vagal nerve stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate changes to transcutaneous vagal nerve stimulation</measure>
    <time_frame>40 minutes</time_frame>
    <description>cardiac response to non-invasive vagal nerve stimulation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>transcutaneous vagal nerve stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypertensive Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>transcutaneous vagal nerve stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcutaneous vagal nerve stimulation on</intervention_name>
    <description>electrical current on positioned in the ear to estimate vagal branch of auricular nerve</description>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_label>Hypertensive Subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcutaneous vagal nerve stimulation off</intervention_name>
    <description>an electrical current off positioned in the ear to estimate vagal branch of auricular nerve</description>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_label>Hypertensive Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Normotensive group Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
          -  sign the consent term&#xD;
&#xD;
        Normotensive group Exclusion Criteria:&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  alcoholism&#xD;
&#xD;
          -  drug treatment&#xD;
&#xD;
          -  skin lesion in the ear region&#xD;
&#xD;
          -  chronic or acute diseases&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  be participating in another research protocol&#xD;
&#xD;
          -  high performance athletes&#xD;
&#xD;
          -  recent surgery&#xD;
&#xD;
          -  vaso-vagal syndrome&#xD;
&#xD;
        Hypertensive group Inclusion Criteria:&#xD;
&#xD;
          -  hypertensive diagnosis (with or without anti-hypertensive drugs treatment) or&#xD;
&#xD;
          -  ambulatory blood pressure monitoring (ABPM) &gt;130/85&#xD;
&#xD;
          -  sign the consent term&#xD;
&#xD;
        Hypertensive group Exclusion Criteria:&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  alcoholism&#xD;
&#xD;
          -  beta-blockers treatment&#xD;
&#xD;
          -  skin lesion in the ear region&#xD;
&#xD;
          -  associated diseases&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  be participating in another research protocol&#xD;
&#xD;
          -  high performance athletes&#xD;
&#xD;
          -  recent surgery&#xD;
&#xD;
          -  vaso-vagal syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>autonomic control</keyword>
  <keyword>transcutaneous vagal nerve stimulation</keyword>
  <keyword>transauricular vagal nerve stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT03000842
org study id: 5260/16
nct id: NCT03000842
lead sponsor: 
has dmc: Yes
The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic
      regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was
      developing a non-invasive device that is able to stimulate the auricular branch of vagal
      nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct
      stimulation of the vagal nerve. However, there are still no strong evidences about it actions
      regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on
      heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at
      rest and after orthostatic position
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Autonomic control response to transcutaneous vagal nerve stimulation
time frame: 40 minutes
description: sympathetic and parasympathetic response to non-invasive vagal nerve stimulation
measure: Blood pressure changes to transcutaneous vagal nerve stimulation
time frame: 40 minutes
description: systemic response to non-invasive vagal nerve stimulation
measure: Heart Rate changes to transcutaneous vagal nerve stimulation
time frame: 40 minutes
description: cardiac response to non-invasive vagal nerve stimulation
arm group label: Healthy Subjects
arm group type: Experimental
description: transcutaneous vagal nerve stimulation
arm group label: Hypertensive Subjects
arm group type: Experimental
description: transcutaneous vagal nerve stimulation
intervention type: Device
intervention name: transcutaneous vagal nerve stimulation on
description: electrical current on positioned in the ear to estimate vagal branch of auricular nerve
arm group label: Healthy Subjects
arm group label: Hypertensive Subjects
intervention type: Device
intervention name: transcutaneous vagal nerve stimulation off
description: an electrical current off positioned in the ear to estimate vagal branch of auricular nerve
arm group label: Healthy Subjects
arm group label: Hypertensive Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hypertension