Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

Study Overview
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Brief Summary
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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

Official Title
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Effects of Transcutaneous Vagal Nerve Stimulation (tVNS) on Blood Pressure, Heart Rate and Autonomic Control in Hypertensive Subjects

Conditions
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Hypertension

Intervention / Treatment
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* Device: transcutaneous vagal nerve stimulation on
* Device: transcutaneous vagal nerve stimulation off


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subjects<br>transcutaneous vagal nerve stimulation | Device: transcutaneous vagal nerve stimulation on<br>* electrical current on positioned in the ear to estimate vagal branch of auricular nerve<br>Device: transcutaneous vagal nerve stimulation off<br>* an electrical current off positioned in the ear to estimate vagal branch of auricular nerve<br>|
| Experimental: Hypertensive Subjects<br>transcutaneous vagal nerve stimulation | Device: transcutaneous vagal nerve stimulation on<br>* electrical current on positioned in the ear to estimate vagal branch of auricular nerve<br>Device: transcutaneous vagal nerve stimulation off<br>* an electrical current off positioned in the ear to estimate vagal branch of auricular nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic control response to transcutaneous vagal nerve stimulation | sympathetic and parasympathetic response to non-invasive vagal nerve stimulation | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure changes to transcutaneous vagal nerve stimulation | systemic response to non-invasive vagal nerve stimulation | 40 minutes | 
| Heart Rate changes to transcutaneous vagal nerve stimulation | cardiac response to non-invasive vagal nerve stimulation | 40 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autonomic control, transcutaneous vagal nerve stimulation, transauricular vagal nerve stimulation