Health, SubjectiveNCT05370027
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
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Health, Subjective, run by Bahçeşehir University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Berkay Eren E. PEHLIVANOGLU, MSc, PhD(c) contact
About this study
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.
- Conditions
- Health, Subjective
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation
- Keywords
- vagus nerve, vagus nerve stimulation, transcutaneous auricular vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| 2nd Group | Experimental | With the vagustim device, the application will be made first from the left ear. Then, a 48-hour break will be made and the application will be made from both ears. Then, the application will be performed on the right ear with a break for 48 hours. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| 3rd Group | Experimental | With the vagustim device, the application will be made first from the right ear. Then, a 48-hour break will be taken and the application will be made from the left ear. Then, the application will be performed on both ears with a 48-hour break. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| 4th Group | Experimental | With the vagustim device, the application will be made first from the right ear. Then, a 48-hour break will be made and the application will be made from both ears. Then, the application will be performed on the left ear with a break for 48 hours. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| 5th Group | Experimental | With the vagustim device, the application will be made from both ears first. Then, a 48-hour break will be made and the application will be made from the left ear. Then, the application will be performed on the right ear with a break for 48 hours. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| 6th Group | Experimental | With the vagustim device, the application will be made from both ears first. Then, a 48-hour break will be made and the application will be made from the right ear. Then, the application will be performed on the left ear with a break for 48 hours. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Omron Hem 7321 E M6 device will be used to measure heart rate
Measured: 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
Measured: Up to 1 week
Evaluation of Galvanic Skin Resistance
Bogazici University GSR device will be used to measure Galvanic Skin Resistance
Measured: Up to 1 week
Heart Rate Variability
Elite HRV device will be used to measure Heart Rate Variability
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start15 Jul 2022 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkay Eren PEHLIVANOGLU, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370027
- Sponsor's protocol ID
- BahcesehirU_B.Pehlivanoglu001
- Status last verified
- Jun 2022
- First submitted
- 26 Apr 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05370027
- Acronym / sponsor ID
- BahcesehirU_B.Pehlivanoglu001
- Conditions
- Health, Subjective
- Keywords
- vagus nerve, vagus nerve stimulation, transcutaneous auricular vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1st Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationWith 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. |
| 2nd Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationWith the vagustim device, the application will be made first from the left ear. Then, a 48-hour break will be made and the application will be made from both ears. Then, the application will be performed on the right ear with a break for 48 hours. |
| 3rd Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationWith the vagustim device, the application will be made first from the right ear. Then, a 48-hour break will be taken and the application will be made from the left ear. Then, the application will be performed on both ears with a 48-hour break. |
| 4th Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationWith the vagustim device, the application will be made first from the right ear. Then, a 48-hour break will be made and the application will be made from both ears. Then, the application will be performed on the left ear with a break for 48 hours. |
| 5th Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationWith the vagustim device, the application will be made from both ears first. Then, a 48-hour break will be made and the application will be made from the left ear. Then, the application will be performed on the right ear with a break for 48 hours. |
| 6th Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationWith the vagustim device, the application will be made from both ears first. Then, a 48-hour break will be made and the application will be made from the right ear. Then, the application will be performed on the left ear with a break for 48 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationVagus 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. | Device | 1st Group, 2nd Group, 3rd Group, 4th Group, 5th Group, 6th Group |
Primary outcome
Heart Rate
Time frame: Up to 1 week
Omron Hem 7321 E M6 device will be used to measure heart rate
Systolic and Diastolic Blood Pressure
Time frame: Up to 1 week
Omron Hem 7321 E M6 device will be used to measure Systolic and Diastolic Blood Pressure
Evaluation of Galvanic Skin Resistance
Time frame: Up to 1 week
Bogazici University GSR device will be used to measure Galvanic Skin Resistance
Heart Rate Variability
Time frame: Up to 1 week
Elite HRV device will be used to measure Heart Rate Variability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berkay Eren E. PEHLIVANOGLU, MSc, PhD(c) contact
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Health, Subjective, run by Bahçeşehir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berkay Eren E. PEHLIVANOGLU, MSc, PhD(c) (00905073337972 ext. Tur, fzt.berkayerenpehlivanoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: Up to 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.