Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects
Conditions
Keywords
vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
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.
Interventions
DEVICEPrimeStim
Intermittent auricular vagus nerve stimulation at different ear points
Sponsors
Vienna University of Technology
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in heart rate variability (HRV) related to stimulation site in the auricle | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | 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. |
| change in local blood perfusion index (BPI) related to stimulation site in the auricle | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in respiratory activity | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | Respiratory activity is monitored using a respiratory belt. |
| 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 | — |
| Change of local BPI in upper and lower extremities | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | 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. |
| Tolerance of stimulation | at each day of intervention at the stimulation cycles | Tolerance of stimulation is assessed by free survey. |
| Perception of Stimulation | at each day of intervention at the stiumulation cycles | Perception of stimulation is assessed by free survey. |
| Adverse effects of stimulation | within 4 days of intervention | — |
| Changes of C reactive protein- and leukocyte-concentration in serum | at screening and at the last day of intervention | — |
| Changes in blood pressure | within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles | Blood pressure is continuously measured using inflatable finger cuffs. |
Countries
Austria
Contacts
Primary ContactJozsef C Széles, Dr.med.
Backup ContactStefan Kampusch, MSc
Outcome results
None listed