Clinical trial NCT02139293: Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters
Official title: Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects
Keywords: vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Vienna University of Technology
First posted: 2014-05-15
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on cardiovascular parameters and sympathovagal balance in healthy subjects. It is investigated if auricular vagal nerve stimulation affects heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the site of stimulation in the auricle, whereas four distinct stimulation points are tested.


Eligibility criteria: Inclusion Criteria:

* men and women aged 20 to 50 years

Exclusion Criteria:

* participation in a clinical trial in the last 5 weeks
* diseases which may affect the autonomous nervous system (e.g., diabetes mellitus)
* confounding medical treatment with known effects on the autonomous nervous system (e.g., beta blocker)
* drug abuse
* active implanted devices
* pregnancy or nursing

Primary outcomes:
measure: change in heart rate variability (HRV) related to stimulation site in the auricle
timeFrame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
measure: change in local blood perfusion index (BPI) related to stimulation site in the auricle
timeFrame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Secondary outcomes:
measure: Change of local BPI in upper and lower extremities
timeFrame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
measure: Changes in blood pressure
timeFrame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
measure: Changes in respiratory activity
timeFrame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
measure: Changes in oxygen saturation of the toe
timeFrame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
measure: Changes in partial transcutaneous oxygen pressure of the forefoot
timeFrame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
measure: Changes in foot skin temperature
timeFrame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
measure: Changes of C reactive protein- and leukocyte-concentration in serum
timeFrame: at screening and at the last day of intervention
measure: Tolerance of stimulation
timeFrame: at each day of intervention at the stimulation cycles
measure: Perception of Stimulation
timeFrame: at each day of intervention at the stiumulation cycles
measure: Adverse effects of stimulation
timeFrame: within 4 days of intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Study officials:
affiliation: University Clinic for Surgery, Department of Transplantation, Medical University Vienna
name: Jozsef C Széles, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: