Autonomic Nervous System ImbalanceNCT06730165
Comparison of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation
A study testing Transcutaneous Auricular Vagus Nerve Stimulation and Transcutaneous Auricular Trigeminal Nerve Stimulation in people with Autonomic Nervous System Imbalance, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the results between transcutaneous auricular vagus nerve stimulation and trigeminal nerve stimulation with the results obtained from heart rate variability, pulse and blood pressure measurements and to reveal which method is more effective in autonomic nervous system… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Imbalance
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation and Transcutaneous Auricular Trigeminal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2024to 10 Sep 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be 18 years of age or older,
- Not having any acute or chronic disease.
Who cannot join
- Having any acute or chronic disease,
- Having previously undergone vagus nerve stimulation or trigeminal nerve stimulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation on Heart Rate Variability
The aim of this study was to compare the results between transcutaneous auricular vagus nerve stimulation and trigeminal nerve stimulation with the results obtained from heart rate variability, pulse and blood pressure measurements and to reveal which method is more effective in autonomic nervous system neuromodulation.
Hypotheses of the study:
H0: Vagus nerve stimulation is more effective than trigeminal nerve simulation in terms of heart rate variability.
H1: Trigeminal nerve stimulation is more effective than vagus nerve simulation in terms of heart rate variability.
Read the detailed description
In this study, 80 healthy participants (40 males, 40 females) aged between 20-50 years were randomized (www.randomizer.org) into four groups by computer software. After randomisation, one group was received transcutaneous vagus nerve stimulation inside the ear, while the other group was received trigeminal nerve stimulation above the ear.The third group received sham transcutaneous vagus nerve stimulation and the fourth group received sham trigeminal nerve simulation. Heart rate variability, pulse rate and blood pressure measurements were performed to determine which stimulation method is more effective. Heart rate variability was analysed with Kubios HRV programme after the 5-minute short measurement method. SNS, PNS and Stress Index and LF, HF and LF/HF parameters were evaluated in heart rate variability sub-parameters.
- Conditions
- Autonomic Nervous System Imbalance
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation, Transcutaneous Auricular Trigeminal Nerve Stimulation
- Keywords
- Vagus Nerve Stimulations, Trigeminal Nerve Stimulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Stimulation of the vagus nerve through the tragus and concha in the ear
Transcutaneous Auricular Trigeminal Nerve StimulationDevice
Stimulation of the trigeminal nerve via the auriculotemporal nerve with a clip electrode from the upper auricle
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Active comparator | Transcutaneous vagus nerve stimulation through the tragus and concha in the ear, Frequency: 25 Hertz, Duration: 20 minutes Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Transcutaneous Auricular Trigeminal Nerve Stimulation | Active comparator | Transcutaneous auricular trigeminal nerve stimulation, Frequency: 25 Hertz, Duration: 20 minutes Receives: Device: Transcutaneous Auricular Trigeminal Nerve Stimulation |
| Sham Transcutaneous Auricular Vagus Nerve Stimulation | Sham comparator | Sham Transcutaneous Auricular Vagus Nerve Stimulation, The device is switched on but the current intensity is off, Duration: 20 minutes Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham Transcutaneous Auricular Trigeminal Nerve Stimulation | Sham comparator | Sham Transcutaneous Auricular Trigeminal Nerve Stimulation, The device is switched on but the current intensity is off, Duration: 20 minutes Receives: Device: Transcutaneous Auricular Trigeminal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
5 minutes of heart rate variability was measured.
Measured: Pre-intervention and immediately after the intervention
Secondary outcomes (1)
Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure was measured with an electronic blood pressure monitor.
Measured: Pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start3 Mar 2024
- Primary completion1 Apr 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous System ImbalanceStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Percin, Bahçeşehir University
- Investigators
- Yavuz Ozoran, Prof., Study chair, Dean of the Health Sciences Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730165
- Sponsor's protocol ID
- Study0009
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.
PubMed 33355897Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.
PubMed 25614179Milby AH, Halpern CH, Baltuch GH. Vagus nerve stimulation for epilepsy and depression. Neurotherapeutics. 2008 Jan;5(1):75-85. doi: 10.1016/j.nurt.2007.10.071.
PubMed 18164486Percin A, Ozden AV, Yenisehir S, Albayrak HE. Autonomic Effects of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation: A Randomized, Sham-Controlled, and Single-Blind Study. Neuromodulation. 2026 Jun;29(4):588-596. doi: 10.1016/j.neurom.2025.09.312. Epub 2025 Oct 27.
PubMed 41143755
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation on Heart Rate Variability
- ClinicalTrials.gov ID
- NCT06730165
- Acronym / sponsor ID
- Study0009
- Conditions
- Autonomic Nervous System Imbalance
- Keywords
- Vagus Nerve Stimulations, Trigeminal Nerve Stimulations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 12 Dec 2024 (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 aim of this study was to compare the results between transcutaneous auricular vagus nerve stimulation and trigeminal nerve stimulation with the results obtained from heart rate variability, pulse and blood pressure measurements and to reveal which method is more effective in autonomic nervous system neuromodulation.
Hypotheses of the study:
H0: Vagus nerve stimulation is more effective than trigeminal nerve simulation in terms of heart rate variability.
H1: Trigeminal nerve stimulation is more effective than vagus nerve simulation in terms of heart rate variability.
Detailed description
In this study, 80 healthy participants (40 males, 40 females) aged between 20-50 years were randomized (www.randomizer.org) into four groups by computer software. After randomisation, one group was received transcutaneous vagus nerve stimulation inside the ear, while the other group was received trigeminal nerve stimulation above the ear.The third group received sham transcutaneous vagus nerve stimulation and the fourth group received sham trigeminal nerve simulation. Heart rate variability, pulse rate and blood pressure measurements were performed to determine which stimulation method is more effective. Heart rate variability was analysed with Kubios HRV programme after the 5-minute short measurement method. SNS, PNS and Stress Index and LF, HF and LF/HF parameters were evaluated in heart rate variability sub-parameters.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation | Active comparator | Device: Transcutaneous Auricular Vagus Nerve StimulationTranscutaneous vagus nerve stimulation through the tragus and concha in the ear, Frequency: 25 Hertz, Duration: 20 minutes |
| Transcutaneous Auricular Trigeminal Nerve Stimulation | Active comparator | Device: Transcutaneous Auricular Trigeminal Nerve StimulationTranscutaneous auricular trigeminal nerve stimulation, Frequency: 25 Hertz, Duration: 20 minutes |
| Sham Transcutaneous Auricular Vagus Nerve Stimulation | Sham comparator | Device: Transcutaneous Auricular Vagus Nerve StimulationSham Transcutaneous Auricular Vagus Nerve Stimulation, The device is switched on but the current intensity is off, Duration: 20 minutes |
| Sham Transcutaneous Auricular Trigeminal Nerve Stimulation | Sham comparator | Device: Transcutaneous Auricular Trigeminal Nerve StimulationSham Transcutaneous Auricular Trigeminal Nerve Stimulation, The device is switched on but the current intensity is off, Duration: 20 minutes |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- To be 18 years of age or older,
- Not having any acute or chronic disease.
Key exclusion criteria (2 listed)
- Having any acute or chronic disease,
- Having previously undergone vagus nerve stimulation or trigeminal nerve stimulation.
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 StimulationStimulation of the vagus nerve through the tragus and concha in the ear | Device | Sham Transcutaneous Auricular Vagus Nerve Stimulation, Transcutaneous Auricular Vagus Nerve Stimulation |
| Transcutaneous Auricular Trigeminal Nerve StimulationStimulation of the trigeminal nerve via the auriculotemporal nerve with a clip electrode from the upper auricle | Device | Sham Transcutaneous Auricular Trigeminal Nerve Stimulation, Transcutaneous Auricular Trigeminal Nerve Stimulation |
Primary outcome
Heart Rate Variability
Time frame: Pre-intervention and immediately after the intervention
5 minutes of heart rate variability was measured.
1 secondary outcome
Systolic and Diastolic Blood Pressure
Time frame: Pre-intervention and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 33355897Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.
- Background: PubMed 25614179Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.
- Background: PubMed 18164486Milby AH, Halpern CH, Baltuch GH. Vagus nerve stimulation for epilepsy and depression. Neurotherapeutics. 2008 Jan;5(1):75-85. doi: 10.1016/j.nurt.2007.10.071.
- Derived from this study: PubMed 41143755Percin A, Ozden AV, Yenisehir S, Albayrak HE. Autonomic Effects of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation: A Randomized, Sham-Controlled, and Single-Blind Study. Neuromodulation. 2026 Jun;29(4):588-596. doi: 10.1016/j.neurom.2025.09.312. Epub 2025 Oct 27.
- Individual participant dataSharing planned: No
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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.
Yavuz Ozoran, Prof. study chair
Dean of the Health Sciences Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation and Transcutaneous Auricular Trigeminal Nerve Stimulation in people with Autonomic Nervous System Imbalance, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06730165, which also lists 4 linked publications.
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 12 Dec 2024.