Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects Clinical Trial
Official title:
Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study
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.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | University Clinic for Surgery, Department of Transplantation, Medical University Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna | Vienna University of Technology |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | |
| Primary | 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. |
within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | |
| Secondary | 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. |
within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | |
| Secondary | Changes in blood pressure | Blood pressure is continuously measured using inflatable finger cuffs. | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | |
| Secondary | Changes in respiratory activity | Respiratory activity is monitored using a respiratory belt. | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | |
| Secondary | Changes in oxygen saturation of the toe | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | ||
| Secondary | Changes in partial transcutaneous oxygen pressure of the forefoot | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | ||
| Secondary | Changes in foot skin temperature | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | ||
| Secondary | Changes of C reactive protein- and leukocyte-concentration in serum | at screening and at the last day of intervention | ||
| Secondary | Tolerance of stimulation | Tolerance of stimulation is assessed by free survey. | at each day of intervention at the stimulation cycles | |
| Secondary | Perception of Stimulation | Perception of stimulation is assessed by free survey. | at each day of intervention at the stiumulation cycles | |
| Secondary | Adverse effects of stimulation | within 4 days of intervention |