Brief Summary

The vagus nerve is one of the main components of the parasympathetic nervous system, which oversees a wide variety of important bodily functions, including mood control, immune response, digestion, and heart rate. It is the tenth cranial nerve originating from the medulla oblongata in the central nervous system and is the longest cranial nerve. It starts from the medulla and progresses to the colon. It mainly innervates the thoracic and abdominal organs. It has an obvious effect on the autonomic nervous system, especially on parasympathetic activity. When the literature is examined, it has been proven by various studies that vagus nerve stimulation has effects on the regulation of the autonomic system. Vagus nerve stimulation with different methods has been investigated over the years and the effectiveness of several different methods has been proven. There are both invasive and non-invasive (transcutaneous) techniques for vagus nerve stimulation. The first experiments were developed on invasive applications, and then non-invasive applications began to emerge. Today, the most used devices and stimulation models were approved by the FDA in the 1990s for use in patients with drug-resistant epilepsy. In the middle of the first decade of the 2000s, the FDA approved the use of these devices for drug-resistant depression. These application methods have therapeutic effects for a wide variety of conditions, including heart failure, obesity, migraine, Alzheimer's, inflammation, chronic pain, and tinnitus. Invasive intervention is not necessary to perform this procedure. Direct stimulation of afferent nerve fibers in the ear can produce a similar effect without surgical intervention. Non-invasive vagus nerve stimulation may affect human physiology and be a simple and inexpensive alternative to invasive vagus stimulation. It has been shown on different subjects that non-invasive stimulation of the tragus in the ear increases the activation in the parasympathetic system and decreases the sympathetic activity. This indicates that tragus stimulation may be a viable treatment for some disorders in which autonomic activity is compromised. While the general mechanism has been explained in this way, there is no definite information in the literature about which ear from the right single ear, double ear or left single ear will be applied in Transcutaneous Auricular Vagus Nerve Stimulation applications. While specifying the application techniques, an objective scientific study about whether there is a difference between Unilateral Right, Unilateral Left and Bilateral Applications or which of them gives more effective results will be a guide for further studies. The purpose of the study, planning to carry out is to seek an answer to one of the questions that come to mind for standardization. The main question we seek to answer is whether there is a difference between Unilateral Right, Unilateral Left and Bilateral Applications while specifying the application techniques, or which of them gives more effective results. This studies main goal is to set up this study in order to seek answers about which application style will produce results and to provide a guide for further studies.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

April 26, 2022

Completed

15 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed

16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed

Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

April 26, 2022

Last Update Submit

June 14, 2022

Conditions

Health, Subjective

Keywords

vagus nervevagus nerve stimulationtranscutaneous auricular vagus nerve stimulation

Outcome Measures

Primary Outcomes (4)

Heart Rate
Omron Hem 7321 E M6 device will be used to measure heart rate
Up to 1 week
Systolic and Diastolic Blood Pressure
Omron Hem 7321 E M6 device will be used to measure Systolic and Diastolic Blood Pressure
Up to 1 week
Evaluation of Galvanic Skin Resistance
Bogazici University GSR device will be used to measure Galvanic Skin Resistance
Up to 1 week
Heart Rate Variability
Elite HRV device will be used to measure Heart Rate Variability
Up to 1 week

Study Arms (6)

1st Group

EXPERIMENTAL

With the vagustim device, the application will be made first from the left ear. Then, a 48-hour break will be taken and the application will be made from the right ear. Then, the application will be performed on both ears with a 48-hour break.