MedDataX Logo

Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters

NCT ID: NCT03000842

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

autonomic control transcutaneous vagal nerve stimulation transauricular vagal nerve stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Subjects

transcutaneous vagal nerve stimulation

Group Type EXPERIMENTAL

transcutaneous vagal nerve stimulation on

Intervention Type DEVICE

electrical current on positioned in the ear to estimate vagal branch of auricular nerve

transcutaneous vagal nerve stimulation off

Intervention Type DEVICE

an electrical current off positioned in the ear to estimate vagal branch of auricular nerve

Hypertensive Subjects

transcutaneous vagal nerve stimulation

Group Type EXPERIMENTAL

transcutaneous vagal nerve stimulation on

Intervention Type DEVICE

electrical current on positioned in the ear to estimate vagal branch of auricular nerve

transcutaneous vagal nerve stimulation off

Intervention Type DEVICE

an electrical current off positioned in the ear to estimate vagal branch of auricular nerve

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transcutaneous vagal nerve stimulation on

electrical current on positioned in the ear to estimate vagal branch of auricular nerve

Intervention Type DEVICE

transcutaneous vagal nerve stimulation off

an electrical current off positioned in the ear to estimate vagal branch of auricular nerve

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy volunteers
* sign the consent term


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

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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5260/16

Identifier Type: -

Identifier Source: org_study_id