Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity

Not Applicable

Completed

• Conditions: Vagus Nerve Stimulation
• Interventions: Device: Transcutaneous Auricular Vagus Nerve Stimulation

• Registration Number: NCT06086236
• Lead Sponsor: Bahçeşehir University

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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-10
• Status Verified: 2023-10
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PNS Index<-2 and SNS Index<2	Transcutaneous Auricular Vagus Nerve Stimulation	Participants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS\<-2, SNS\<2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
PNS Index>-2 and SNS Index>2	Transcutaneous Auricular Vagus Nerve Stimulation	Participants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS\>-2, SNS\>2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
PNS Index<-2 and SNS Index>2	Transcutaneous Auricular Vagus Nerve Stimulation	Participants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS\<-2, SNS\>2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
PNS Index>-2 and SNS Index<2	Transcutaneous Auricular Vagus Nerve Stimulation	Participants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS\>-2, SNS\<2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	Up to 6 Months	The systolic blood pressure of the participants was measured with an electronic blood pressure monitor.
Diastolic Blood Pressure	Up to 6 Months	The diastolic blood pressure of the participants was measured with an electronic blood pressure monitor.
Pulse Rate	Up to 6 Months	The pulse rate of the participants was measured with an electronic blood pressure monitor.

Trial Locations

Locations (1)

Igdir University; 🇹🇷 Iğdır, Merkez, Turkey