Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

Not Applicable

• Conditions: Hypertension
• Interventions: Device: transcutaneous vagal nerve stimulation on; Device: transcutaneous vagal nerve stimulation off

• Registration Number: NCT03000842
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-21
• Last Update Submitted: 2016-12-21
• Study First Posted: 2016-12-22
• Last Update Posted: 2016-12-22
• Study Start: 2017-01
• Primary Completion: 2017-03
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	transcutaneous vagal nerve stimulation off	transcutaneous vagal nerve stimulation
Hypertensive Subjects	transcutaneous vagal nerve stimulation on	transcutaneous vagal nerve stimulation
Healthy Subjects	transcutaneous vagal nerve stimulation on	transcutaneous vagal nerve stimulation
Hypertensive Subjects	transcutaneous vagal nerve stimulation off	transcutaneous vagal nerve stimulation

Primary Outcome Measures

Name	Time	Method
Autonomic control response to transcutaneous vagal nerve stimulation	40 minutes	sympathetic and parasympathetic response to non-invasive vagal nerve stimulation

Secondary Outcome Measures

Name	Time	Method
Heart Rate changes to transcutaneous vagal nerve stimulation	40 minutes	cardiac response to non-invasive vagal nerve stimulation
Blood pressure changes to transcutaneous vagal nerve stimulation	40 minutes	systemic response to non-invasive vagal nerve stimulation