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| Name | Class |
|---|---|
| Vienna University of Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| auricular vagus nerve stimulation | Experimental | Study participants (healthy) are treated with auricular vagus nerve stimulation using five needle electrodes connected to an electrical stimulation device (PrimeStim). After acclimatization the stimulation is turned on for 20 minutes followed by 20 minutes of paused stimulation, 20 minutes of stimulation, and 10 minutes paused stimulation. This intervention is repeated on four consecutive days, whereas at each intervention only one of the four stimulation points (and one fixed reference point) is stimulated. Needle electrodes are applied at each study visit. Stimulation points in the auricle are stimulated in random order. One stimulation pattern is tested. Stimulation amplitudes are adjusted with respect to a distinct but comfortable sensation at the auricle. During the described protocol various biosignals are continuously recorded, including ECG, respiration, blood perfusion, oxygen saturation, transcutaneous oxygen tension, blood pressure and skin temperature. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrimeStim | Device | Intermittent auricular vagus nerve stimulation at different ear points |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jozsef C Széles, Dr.med. | Contact | +4367687832013 | jozsef.szeles@meduniwien.ac.at | |
| Stefan Kampusch, MSc | Contact | stefan.kampusch@tuwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Jozsef C Széles, Dr.med. | University Clinic for Surgery, Department of Transplantation, Medical University Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic for Surgery, Department of Transplantation, Medical University Vienna | Vienna | 1090 | Austria |
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| 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 |
| 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 |
| Changes in oxygen saturation of the toe | 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 | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles |
| Changes in foot skin temperature | 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 | at screening and at the last day of intervention |
| Tolerance of stimulation | Tolerance of stimulation is assessed by free survey. | at each day of intervention at the stimulation cycles |
| Perception of Stimulation | Perception of stimulation is assessed by free survey. | at each day of intervention at the stiumulation cycles |
| Adverse effects of stimulation | within 4 days of intervention |