Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03000842
Other study ID # 5260/16
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 20, 2016
Last updated December 21, 2016
Start date January 2017
Est. completion date June 2017

Study information

Verified date December 2016
Source Instituto de Cardiologia do Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date June 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 59 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
transcutaneous vagal nerve stimulation on
electrical current on positioned in the ear to estimate vagal branch of auricular nerve
transcutaneous vagal nerve stimulation off
an electrical current off positioned in the ear to estimate vagal branch of auricular nerve

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Outcome

Type Measure Description Time frame Safety issue
Primary Autonomic control response to transcutaneous vagal nerve stimulation sympathetic and parasympathetic response to non-invasive vagal nerve stimulation 40 minutes No
Secondary Blood pressure changes to transcutaneous vagal nerve stimulation systemic response to non-invasive vagal nerve stimulation 40 minutes No
Secondary Heart Rate changes to transcutaneous vagal nerve stimulation cardiac response to non-invasive vagal nerve stimulation 40 minutes No
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A
Completed NCT03875768 - Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure N/A