Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

Instituto de Cardiologia do Rio Grande do Sul28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Autonomic control response to transcutaneous vagal nerve stimulation

sympathetic and parasympathetic response to non-invasive vagal nerve stimulation

Time frame: 40 minutes

Secondary Outcomes

Blood pressure changes to transcutaneous vagal nerve stimulation

systemic response to non-invasive vagal nerve stimulation

Time frame: 40 minutes

Heart Rate changes to transcutaneous vagal nerve stimulation

cardiac response to non-invasive vagal nerve stimulation

Time frame: 40 minutes