Clinical trial NCT06086236: Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity
Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Basic Autonomic Nervous System Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vagus Nerve Stimulation
Keywords: Vagus Nerve Stimulations
Diastolic Pressure
Pulse Rate
Systolic Pressure
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After the participants were included in the study, heart rate variability was measured and divided into 4 groups according to PNS and SNS indexes.
Primary purpose: TREATMENT

Brief summary: Transcutaneous Auricular Vagus nerve stimulation may be successful in cardiac modulation because of the cardiac connections of the vagal nerve. Therefore, in order to observe the cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood pressure after transcutaneous auricular vagus nerve stimulation application.

Detailed description: Participants were divided into four groups (Figure 1) according to PNS and SNS indexes as Group 1 (PNS index \<-2, SNS index \>+2), Group 2 (PNS index \<-2, SNS index \<+2), Group 3 (PNS index \>-2, SNS index \>+2), Group 4 (PNS index \>-2, SNS index \<+2). Participants were assessed with blood pressure, pulse rate and HRV before and after taVNS stimulation. Sympathetic nervous system (SNS) index and parasympathetic nervous system (PNS) index values were assumed to be between -2 and +2 (95%) in the normal population according to Kubios software, and the grouping method was based on this situation.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40 years old.
* No previous vagus nerve stimulation

Exclusion Criteria:

* Using of any drug, alcohol or smoking.
* Pregnancy.
* Known history of acute or chronic illness.
* Being in the post or peri-menopausal stage.

Primary outcomes:
measure: Pulse Rate
timeFrame: Up to 6 Months
measure: Systolic Blood Pressure
timeFrame: Up to 6 Months
measure: Diastolic Blood Pressure
timeFrame: Up to 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Iğdır
country: Turkey
facility: Igdir University
state: Merkez
Study officials:
affiliation: Igdir University
name: Alper Perçin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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