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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
Intermittent auricular vagus nerve stimulation at different ear points
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Vienna, Austria
change in heart rate variability (HRV) related to stimulation site in the auricle
Heart rate variability will be assessed as, e.g., standard deviation in heart rate over a time window of 5 minutes (2.5 minutes overlap), total power or low to high frequency power. Changes in assessed heart rate variability parameters will be assessed and compared between subjects with respect to stimulation site using statistical tests.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
change in local blood perfusion index (BPI) related to stimulation site in the auricle
Blood perfusion index at the foot will be assessed as peak-peak amplitude (systolic to diastolic) divided by the mean signal value of optically measured blood perfusion. Changes in mean value and standard deviation of local blood perfusion index will be assessed and compared between subjects with respect to stimulation site using statistical tests.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Change of local BPI in upper and lower extremities
Local BPI is assessed using optical sensors on the foot and the finger of participants. Changes in mean value of BPI are analyzed using statistical tests.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in blood pressure
Blood pressure is continuously measured using inflatable finger cuffs.
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in respiratory activity
Respiratory activity is monitored using a respiratory belt.
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Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in oxygen saturation of the toe
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in partial transcutaneous oxygen pressure of the forefoot
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in foot skin temperature
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes of C reactive protein- and leukocyte-concentration in serum
Time frame: at screening and at the last day of intervention
Tolerance of stimulation
Tolerance of stimulation is assessed by free survey.
Time frame: at each day of intervention at the stimulation cycles
Perception of Stimulation
Perception of stimulation is assessed by free survey.
Time frame: at each day of intervention at the stiumulation cycles
Adverse effects of stimulation
Time frame: within 4 days of intervention