Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters
1 other identifier
interventional
28
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Jan 2017
Shorter than P25 for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2016
CompletedFirst Posted
Study publicly available on registry
December 22, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 22, 2016
December 1, 2016
2 months
December 20, 2016
December 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Autonomic control response to transcutaneous vagal nerve stimulation
sympathetic and parasympathetic response to non-invasive vagal nerve stimulation
40 minutes
Secondary Outcomes (2)
Blood pressure changes to transcutaneous vagal nerve stimulation
40 minutes
Heart Rate changes to transcutaneous vagal nerve stimulation
40 minutes
Study Arms (2)
Healthy Subjects
EXPERIMENTALtranscutaneous vagal nerve stimulation
Hypertensive Subjects
EXPERIMENTALtranscutaneous vagal nerve stimulation
Interventions
electrical current on positioned in the ear to estimate vagal branch of auricular nerve
an electrical current off positioned in the ear to estimate vagal branch of auricular nerve
Eligibility Criteria
You may qualify if:
- healthy volunteers
- sign the consent term
You may not qualify if:
- 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 diagnosis (with or without anti-hypertensive drugs treatment) or
- ambulatory blood pressure monitoring (ABPM) \>130/85
- sign the consent term
- smokers
- alcoholism
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2016
First Posted
December 22, 2016
Study Start
January 1, 2017
Primary Completion
March 1, 2017
Study Completion
June 1, 2017
Last Updated
December 22, 2016
Record last verified: 2016-12