Investigation of the Effect of Unilateral Right, Unilateral Left and Bilateral Applications of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Nervous System Activity in Healthy People

Health, Subjective Clinical Trial

Official title:

Investigation of the Effect of Unilateral Right, Unilateral Left and Bilateral Applications of Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Nervous System Activity in Healthy People

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05370027
• Other study ID #: BahcesehirU_B.Pehlivanoglu001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: June 2022
• Source: Bahçesehir University
• Contact: Berkay Eren E. PEHLIVANOGLU, MSc, PhD(c)
• Phone: 00905073337972
• Email: fzt.berkayerenpehlivanoglu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 15, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Volunteering to participate in the study

• Have signed the informed consent form

• The volunteer has no disease before or during the study

• Absence of menstrual cycle period in female volunteers

• The subject did not drink alcohol 24 hours before the study

Exclusion Criteria:

• Cases unwilling to continue the study.

• Having a respiratory disease and starting to use drugs

• Having a disease related to the cardiac system and starting to use drugs

• The presence of any chronic disease and the use of a drug related to it

Related Conditions & MeSH terms

• Health, Subjective

Intervention

Device:
• Transcutaneous Auricular Vagus Nerve Stimulation
Vagus nerve stimulation will be applied with the Vagustim device for 20 (10+10) minutes, with a biphasic frequency, a frequency of 10 Hz, a pulse width of 300 µs in Modulation mode, and a constant current intensity where the participant feels the current comfortably.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bahçesehir University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Omron Hem 7321 E M6 device will be used to measure heart rate	Up to 1 week
Primary	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
Primary	Evaluation of Galvanic Skin Resistance	Bogazici University GSR device will be used to measure Galvanic Skin Resistance	Up to 1 week
Primary	Heart Rate Variability	Elite HRV device will be used to measure Heart Rate Variability	Up to 1 week