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Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcutaneous vagal nerve stimulation on
transcutaneous vagal nerve stimulation off
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension focused on measuring autonomic control, transcutaneous vagal nerve stimulation, transauricular vagal nerve stimulation

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Normotensive group Inclusion Criteria:

  • healthy volunteers
  • sign the consent term

Normotensive group Exclusion Criteria:

  • smokers
  • alcoholism
  • drug treatment
  • skin lesion in the ear region
  • chronic or acute diseases
  • pregnancy
  • be participating in another research protocol
  • high performance athletes
  • recent surgery
  • vaso-vagal syndrome

Hypertensive group Inclusion Criteria:

  • hypertensive diagnosis (with or without anti-hypertensive drugs treatment) or
  • ambulatory blood pressure monitoring (ABPM) >130/85
  • sign the consent term

Hypertensive group Exclusion Criteria:

  • smokers
  • alcoholism
  • beta-blockers treatment
  • skin lesion in the ear region
  • associated diseases
  • pregnancy
  • be participating in another research protocol
  • high performance athletes
  • recent surgery
  • vaso-vagal syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Healthy Subjects

    Hypertensive Subjects

    Arm Description

    transcutaneous vagal nerve stimulation

    transcutaneous vagal nerve stimulation

    Outcomes

    Primary Outcome Measures

    Autonomic control response to transcutaneous vagal nerve stimulation
    sympathetic and parasympathetic response to non-invasive vagal nerve stimulation

    Secondary Outcome Measures

    Blood pressure changes to transcutaneous vagal nerve stimulation
    systemic response to non-invasive vagal nerve stimulation
    Heart Rate changes to transcutaneous vagal nerve stimulation
    cardiac response to non-invasive vagal nerve stimulation

    Full Information

    First Posted
    December 20, 2016
    Last Updated
    December 21, 2016
    Sponsor
    Instituto de Cardiologia do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03000842
    Brief Title
    Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters
    Official Title
    Effects of Transcutaneous Vagal Nerve Stimulation (tVNS) on Blood Pressure, Heart Rate and Autonomic Control in Hypertensive Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Cardiologia do Rio Grande do Sul

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    autonomic control, transcutaneous vagal nerve stimulation, transauricular vagal nerve stimulation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Subjects
    Arm Type
    Experimental
    Arm Description
    transcutaneous vagal nerve stimulation
    Arm Title
    Hypertensive Subjects
    Arm Type
    Experimental
    Arm Description
    transcutaneous vagal nerve stimulation
    Intervention Type
    Device
    Intervention Name(s)
    transcutaneous vagal nerve stimulation on
    Intervention Description
    electrical current on positioned in the ear to estimate vagal branch of auricular nerve
    Intervention Type
    Device
    Intervention Name(s)
    transcutaneous vagal nerve stimulation off
    Intervention Description
    an electrical current off positioned in the ear to estimate vagal branch of auricular nerve
    Primary Outcome Measure Information:
    Title
    Autonomic control response to transcutaneous vagal nerve stimulation
    Description
    sympathetic and parasympathetic response to non-invasive vagal nerve stimulation
    Time Frame
    40 minutes
    Secondary Outcome Measure Information:
    Title
    Blood pressure changes to transcutaneous vagal nerve stimulation
    Description
    systemic response to non-invasive vagal nerve stimulation
    Time Frame
    40 minutes
    Title
    Heart Rate changes to transcutaneous vagal nerve stimulation
    Description
    cardiac response to non-invasive vagal nerve stimulation
    Time Frame
    40 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Normotensive group Inclusion Criteria: healthy volunteers sign the consent term Normotensive group Exclusion Criteria: smokers alcoholism drug treatment skin lesion in the ear region chronic or acute diseases pregnancy be participating in another research protocol high performance athletes recent surgery vaso-vagal syndrome Hypertensive group Inclusion Criteria: hypertensive diagnosis (with or without anti-hypertensive drugs treatment) or ambulatory blood pressure monitoring (ABPM) >130/85 sign the consent term Hypertensive group Exclusion Criteria: smokers alcoholism beta-blockers treatment skin lesion in the ear region associated diseases pregnancy be participating in another research protocol high performance athletes recent surgery vaso-vagal syndrome

    12. IPD Sharing Statement

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    Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

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