Vagus Nerve StimulationstaVNS-SPIRONCT07482930
Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial
A study testing Transcutaneous auricular vagus nerve stimulation in people with Vagus Nerve Stimulations and Spirometry, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
Trial summary
This study will examine the short-term effects of transcutaneous auricular vagus nerve stimulation (a non-invasive electrical stimulation delivered through the outer ear) on lung function measured by spirometry in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vagus Nerve Stimulations, Spirometry, Autonomic Nervous System (ANS) Functioning and Mood State
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2026to 25 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-40 years.
- Healthy volunteers.
- Able to perform spirometry and follow study instructions.
- Provided written informed consent.
Who cannot join
- Any cardiovascular disease, cardiac arrhythmia, hypertension, or related condition.
- Any neurological disorder (e.g., diabetes mellitus, peripheral neuropathy, epilepsy).
- Any diagnosed psychiatric disorder.
- Any respiratory disease (e.g., asthma, chronic obstructive pulmonary disease).
- Pregnancy or suspected pregnancy.
- Ear conditions that prevent stimulation (infection, open wound, pain/tenderness) or presence of a piercing at/near the stimulation site.
Show all 10Show fewer
- Vigorous exercise within 24 hours prior to measurement.
- Caffeine intake, smoking, or alcohol consumption within 4-6 hours prior to measurement.
- Marked intolerance or hypersensitivity to the device or the procedure.
- Inability to follow instructions during measurements or refusal to complete the session.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, 57900, Türkeli, Sinop, Türkiye
Sinop, 57900
Uğur BAĞCI, PT, MSc
Mesut ARSLAN, MSc, PhD
About this study
Official title: Acute Effects Transcutaneous Auricular Vagus Nerve Stimulation on Spirometric Parameters in Healthy Individuals: A Sham-Controlled Randomized Study
This study will examine the short-term effects of transcutaneous auricular vagus nerve stimulation (a non-invasive electrical stimulation delivered through the outer ear) on lung function measured by spirometry in healthy adults. The vagus nerve is involved in many automatic body functions, and ear-based stimulation has been used in research to explore its possible effects on different physiological systems. However, it is not clear whether a brief stimulation session can acutely influence breathing test results in people without respiratory disease.
Healthy volunteers aged 18-40 will take part in one laboratory visit. Participants will be randomly assigned to one of two groups: (1) active bilateral stimulation applied to specific ear regions that are known to be innervated by the vagus nerve, or (2) sham stimulation using the same device setup but designed to minimize vagal activation. The stimulation session will last approximately 10 minutes. Before and after the stimulation, participants will perform standard spirometry (breathing) tests. Primary spirometric outcomes will include common measures of lung function such as forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). Heart rate, heart rate variability, and blood pressure may also be recorded to monitor physiological responses and safety during the visit.
Participation is voluntary and participants may withdraw at any time. The procedure is considered minimal risk. Possible side effects are usually mild and temporary, such as tingling, warmth, or mild discomfort at the ear. Rarely, participants may feel lightheaded; if this occurs, the procedure will be stopped and the participant will be monitored until symptoms resolve. There is no guaranteed direct benefit to participants. The results may help clarify whether short-term ear-based vagus nerve stimulation can influence spirometric parameters and may inform future studies on autonomic and respiratory interactions.
Read the detailed description
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation approach delivered through the external ear. The auricular branch of the vagus nerve provides an accessible peripheral route that may influence autonomic regulation and, through autonomic-respiratory interactions, potentially affect respiratory function. Although taVNS has been investigated across several physiological domains, evidence regarding its acute effects on spirometric outcomes in healthy individuals remains limited. This study is designed to evaluate whether a single, brief session of bilateral taVNS produces measurable short-term changes in standard spirometric parameters compared with a sham procedure.
This is a sham-controlled, randomized, single-blind, parallel-group trial conducted in healthy volunteers. Participants are allocated to either active bilateral taVNS or sham stimulation using a predefined randomization procedure and concealed assignment. To minimize expectancy effects, participants are blinded to group allocation, and active and sham procedures use the same device appearance and session structure. Active stimulation is delivered via electrodes positioned on auricular regions targeted for vagal innervation, whereas sham stimulation uses an alternative placement intended to minimize vagal activation while maintaining a similar sensory experience. Stimulation parameters are standardized across participants, with intensity individually titrated to a clearly perceptible but non-painful level.
The primary outcomes are acute pre-to-post changes in spirometric measures obtained using standardized spirometry procedures. Key spirometric endpoints include forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). Secondary physiological measures may include heart rate, heart rate variability indices, and blood pressure to characterize autonomic and hemodynamic responses and to support safety monitoring during the session. All measurements are collected within the same visit, with spirometry performed immediately before and after the stimulation procedure following consistent instructions and quality criteria.
Data analysis will focus on between-group comparisons of change scores (post minus pre) for spirometric outcomes. Depending on distributional assumptions, analyses will use appropriate parametric or non-parametric methods; when relevant, models adjusting for baseline values will be applied (e.g., ANCOVA with baseline spirometry as a covariate). Effect sizes and confidence intervals will be reported to support interpretability. Safety will be monitored throughout the visit; stimulation will be discontinued if a participant experiences significant discomfort or requests stopping.
The study involves minimal risk. Expected adverse effects are transient and mild (e.g., localized tingling or mild discomfort at the ear). Rarely, lightheadedness may occur; participants will be monitored and the procedure stopped if necessary. Data will be stored in a coded/de-identified format and reported at the group level.
- Conditions
- Vagus Nerve Stimulations, Spirometry, Autonomic Nervous System (ANS) Functioning and Mood State, Blood Pressure Monitoring, Respiratory Function Tests
- Being tested
- Transcutaneous auricular vagus nerve stimulation, Sham transcutaneous auricular stimulation
- Keywords
- transcutaneous auricular vagus nerve stimulation, spirometry, autonomic nervous system, sham stimulation, pulmonary function test, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagus nerve stimulationDevice
Transcutaneous auricular vagus nerve stimulation is delivered bilaterally using an external stimulator with electrodes placed on auricular regions targeted for vagal innervation (e.g., cymba conchae). Stimulation is applied for approximately 10 minutes. Parameters are standardized (e.g., 25 Hz; pulse width 200-300 microseconds), and current intensity is individually adjusted to a clearly perceptible but non-painful level. The procedure is performed in a single visit with pre- and post-intervention spirometry and physiological monitoring as specified in the protocol.
Sham transcutaneous auricular stimulationDevice
Sham stimulation uses the same device, setup, and session duration to mimic the active procedure. Electrodes are placed on an ear location intended to minimize vagal activation (e.g., ear lobule), and stimulation is delivered at a minimal/low level to provide a similar sensation without therapeutic vagal stimulation. Pre- and post-session spirometry and other measurements are collected identically to the active arm.
| Study group | Role | What they receive |
|---|---|---|
| Active bilateral auricular vagus nerve stimulation | Experimental | Participants receive active bilateral transcutaneous auricular vagus nerve stimulation using an external stimulator. Electrodes are placed on auricular regions targeted for vagal innervation (bilaterally). Stimulation is applied for approximately 10 minutes with standardized parameters and individually adjusted intensity to a clearly perceptible but non-painful level. Spirometry (e.g., FVC, FEV1, PEF) is performed before and after the session; heart rate, heart rate variability, and blood pressure may also be recorded. Receives: Device: Transcutaneous auricular vagus nerve stimulation |
| Sham auricular stimulation (control) | Sham comparator | Participants receive sham stimulation using the same device appearance and session structure. Electrodes are placed on an ear location intended to minimize vagal activation (e.g., ear lobule), and stimulation is delivered at a minimal/low level to mimic sensation without therapeutic stimulation. The same pre- and post-session spirometry and physiological measurements are collected as in the active arm. Receives: Device: Sham transcutaneous auricular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expiratory volume in 1 second (FEV1)
Forced expiratory volume in 1 second (FEV1), reported in liters (L), will be measured immediately before and immediately after the intervention. The outcome will be defined as the pre-to-post change (post minus pre), and between-group differences in change between active stimulation and sham control will be evaluated.[FVC], and peak expiratory flow [PEF]) will be measured immediately before and immediately after the intervention. The primary endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in forced vital capacity (FVC)
Forced vital capacity (FVC), reported in liters (L), will be measured immediately before and immediately after the intervention. The outcome will be defined as the pre-to-post change (post minus pre), and between-group differences in change between active stimulation and sham control will be evaluated.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in peak expiratory flow (PEF)
Peak expiratory flow (PEF), reported in liters per minute (L/min), will be measured immediately before and immediately after the intervention. The outcome will be defined as the pre-to-post change (post minus pre), and between-group differences in change between active stimulation and sham control will be evaluated.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Secondary outcomes (8)
Change in RMSSD from chest recordings
Heart rate variability will be recorded from chest-based beat-to-beat intervals before and after the intervention in a standardized resting condition. The root mean square of successive differences (RMSSD), reported in milliseconds (ms), will be derived from these recordings. The endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active bilateral stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in SDNN from chest recordings
Heart rate variability will be recorded from chest-based beat-to-beat intervals before and after the intervention in a standardized resting condition. The standard deviation of normal-to-normal intervals (SDNN), reported in milliseconds (ms), will be derived from these recordings. The endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active bilateral stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in LF power from chest recordings
Heart rate variability will be recorded from chest-based beat-to-beat intervals before and after the intervention in a standardized resting condition. Low-frequency (LF) power, reported in milliseconds squared (ms²), will be derived from these recordings. The endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active bilateral stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in HF power from chest recordings
Heart rate variability will be recorded from chest-based beat-to-beat intervals before and after the intervention in a standardized resting condition. High-frequency (HF) power, reported in milliseconds squared (ms²), will be derived from these recordings. The endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active bilateral stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in LF/HF ratio from chest recordings
Heart rate variability will be recorded from chest-based beat-to-beat intervals before and after the intervention in a standardized resting condition. The low-frequency/high-frequency (LF/HF) ratio, reported as a unitless measure, will be derived from these recordings. The endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active bilateral stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in systolic blood pressure (SBP)
Systolic blood pressure (SBP), reported in millimeters of mercury (mmHg), will be measured before and after the intervention under standardized conditions. The endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in diastolic blood pressure (DBP)
Diastolic blood pressure (DBP), reported in millimeters of mercury (mmHg), will be measured before and after the intervention under standardized conditions. The endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in heart rate
Heart rate, reported in beats per minute (bpm), will be measured before and after the intervention under standardized conditions. The endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active stimulation and sham control.
Measured: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start17 Mar 2026
- Primary completion20 Apr 2026 (estimated)
- Study completion25 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve StimulationsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, sham-controlled, randomized, single-blind trial. Healthy volunteers are randomly assigned to either active bilateral transcutaneous auricular vagus nerve stimulation or a sham stimulation condition. Spirometric outcomes (e.g., FVC, FEV1, PEF) are measured pre- and post-intervention within a single visit, and between-group differences in change scores are compared.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Collaborators
- Sinop University
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482930
- Sponsor's protocol ID
- taVNS2
- Other IDs
- BEU-IRB 2026/02-1
- Acronym
- taVNS-SPIRO
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared at this time. Study results will be reported in the manuscript in aggregated form. De-identified IPD may be made available upon reasonable request by contacting the corresponding author, subject to appropriate ethical and institutional approvals and data-use conditions.
Publications
Paleczny B, Seredynski R, Ponikowska B. Inspiratory- and expiratory-gated transcutaneous vagus nerve stimulation have different effects on heart rate in healthy subjects: preliminary results. Clin Auton Res. 2021 Apr;31(2):205-214. doi: 10.1007/s10286-019-00604-0. Epub 2019 Apr 2.
PubMed 30941526Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
PubMed 18839484Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
PubMed 27330520Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
PubMed 8598068Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
PubMed 36543841Wang L, Wang Y, Wang Y, Wang F, Zhang J, Li S, Wu M, Li L, Rong P. Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Expert Rev Med Devices. 2022 Jan;19(1):43-61. doi: 10.1080/17434440.2022.2020095. Epub 2022 Jan 13.
PubMed 34937487Zou N, Zhou Q, Zhang Y, Xin C, Wang Y, Claire-Marie R, Rong P, Gao G, Li S. Transcutaneous auricular vagus nerve stimulation as a novel therapy connecting the central and peripheral systems: a review. Int J Surg. 2024 Aug 1;110(8):4993-5006. doi: 10.1097/JS9.0000000000001592.
PubMed 38729100
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects Transcutaneous Auricular Vagus Nerve Stimulation on Spirometric Parameters in Healthy Individuals: A Sham-Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT07482930
- Acronym / sponsor ID
- taVNS-SPIRO / taVNS2
- Conditions
- Vagus Nerve Stimulations, Spirometry, Autonomic Nervous System (ANS) Functioning and Mood State, Blood Pressure Monitoring, Respiratory Function Tests
- Keywords
- transcutaneous auricular vagus nerve stimulation, spirometry, autonomic nervous system, sham stimulation, pulmonary function test, blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Collaborators
- Sinop University
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 25 Apr 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
This study will examine the short-term effects of transcutaneous auricular vagus nerve stimulation (a non-invasive electrical stimulation delivered through the outer ear) on lung function measured by spirometry in healthy adults. The vagus nerve is involved in many automatic body functions, and ear-based stimulation has been used in research to explore its possible effects on different physiological systems. However, it is not clear whether a brief stimulation session can acutely influence breathing test results in people without respiratory disease.
Healthy volunteers aged 18-40 will take part in one laboratory visit. Participants will be randomly assigned to one of two groups: (1) active bilateral stimulation applied to specific ear regions that are known to be innervated by the vagus nerve, or (2) sham stimulation using the same device setup but designed to minimize vagal activation. The stimulation session will last approximately 10 minutes. Before and after the stimulation, participants will perform standard spirometry (breathing) tests. Primary spirometric outcomes will include common measures of lung function such as forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). Heart rate, heart rate variability, and blood pressure may also be recorded to monitor physiological responses and safety during the visit.
Participation is voluntary and participants may withdraw at any time. The procedure is considered minimal risk. Possible side effects are usually mild and temporary, such as tingling, warmth, or mild discomfort at the ear. Rarely, participants may feel lightheaded; if this occurs, the procedure will be stopped and the participant will be monitored until symptoms resolve. There is no guaranteed direct benefit to participants. The results may help clarify whether short-term ear-based vagus nerve stimulation can influence spirometric parameters and may inform future studies on autonomic and respiratory interactions.
Detailed description
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation approach delivered through the external ear. The auricular branch of the vagus nerve provides an accessible peripheral route that may influence autonomic regulation and, through autonomic-respiratory interactions, potentially affect respiratory function. Although taVNS has been investigated across several physiological domains, evidence regarding its acute effects on spirometric outcomes in healthy individuals remains limited. This study is designed to evaluate whether a single, brief session of bilateral taVNS produces measurable short-term changes in standard spirometric parameters compared with a sham procedure.
This is a sham-controlled, randomized, single-blind, parallel-group trial conducted in healthy volunteers. Participants are allocated to either active bilateral taVNS or sham stimulation using a predefined randomization procedure and concealed assignment. To minimize expectancy effects, participants are blinded to group allocation, and active and sham procedures use the same device appearance and session structure. Active stimulation is delivered via electrodes positioned on auricular regions targeted for vagal innervation, whereas sham stimulation uses an alternative placement intended to minimize vagal activation while maintaining a similar sensory experience. Stimulation parameters are standardized across participants, with intensity individually titrated to a clearly perceptible but non-painful level.
The primary outcomes are acute pre-to-post changes in spirometric measures obtained using standardized spirometry procedures. Key spirometric endpoints include forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF). Secondary physiological measures may include heart rate, heart rate variability indices, and blood pressure to characterize autonomic and hemodynamic responses and to support safety monitoring during the session. All measurements are collected within the same visit, with spirometry performed immediately before and after the stimulation procedure following consistent instructions and quality criteria.
Data analysis will focus on between-group comparisons of change scores (post minus pre) for spirometric outcomes. Depending on distributional assumptions, analyses will use appropriate parametric or non-parametric methods; when relevant, models adjusting for baseline values will be applied (e.g., ANCOVA with baseline spirometry as a covariate). Effect sizes and confidence intervals will be reported to support interpretability. Safety will be monitored throughout the visit; stimulation will be discontinued if a participant experiences significant discomfort or requests stopping.
The study involves minimal risk. Expected adverse effects are transient and mild (e.g., localized tingling or mild discomfort at the ear). Rarely, lightheadedness may occur; participants will be monitored and the procedure stopped if necessary. Data will be stored in a coded/de-identified format and reported at the group level.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group, sham-controlled, randomized, single-blind trial. Healthy volunteers are randomly assigned to either active bilateral transcutaneous auricular vagus nerve stimulation or a sham stimulation condition. Spirometric outcomes (e.g., FVC, FEV1, PEF) are measured pre- and post-intervention within a single visit, and between-group differences in change scores are compared.
| Arm | Type | Receives |
|---|---|---|
| Active bilateral auricular vagus nerve stimulation | Experimental | Device: Transcutaneous auricular vagus nerve stimulationParticipants receive active bilateral transcutaneous auricular vagus nerve stimulation using an external stimulator. Electrodes are placed on auricular regions targeted for vagal innervation (bilaterally). Stimulation is applied for approximately 10 minutes with standardized parameters and individually adjusted intensity to a clearly perceptible but non-painful level. Spirometry (e.g., FVC, FEV1, PEF) is performed before and after the session; heart rate, heart rate variability, and blood pressure may also be recorded. |
| Sham auricular stimulation (control) | Sham comparator | Device: Sham transcutaneous auricular stimulationParticipants receive sham stimulation using the same device appearance and session structure. Electrodes are placed on an ear location intended to minimize vagal activation (e.g., ear lobule), and stimulation is delivered at a minimal/low level to mimic sensation without therapeutic stimulation. The same pre- and post-session spirometry and physiological measurements are collected as in the active arm. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-40 years.
- Healthy volunteers.
- Able to perform spirometry and follow study instructions.
- Provided written informed consent.
Key exclusion criteria (10 listed)
- Any cardiovascular disease, cardiac arrhythmia, hypertension, or related condition.
- Any neurological disorder (e.g., diabetes mellitus, peripheral neuropathy, epilepsy).
- Any diagnosed psychiatric disorder.
- Any respiratory disease (e.g., asthma, chronic obstructive pulmonary disease).
- Pregnancy or suspected pregnancy.
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 stimulationTranscutaneous auricular vagus nerve stimulation is delivered bilaterally using an external stimulator with electrodes placed on auricular regions targeted for vagal innervation (e.g., cymba conchae). Stimulation is applied for approximately 10 minutes. Parameters are standardized (e.g., 25 Hz; pulse width 200-300 microseconds), and current intensity is individually adjusted to a clearly perceptible but non-painful level. The procedure is performed in a single visit with pre- and post-intervention spirometry and physiological monitoring as specified in the protocol. | Device | Active bilateral auricular vagus nerve stimulation |
| Sham transcutaneous auricular stimulationSham stimulation uses the same device, setup, and session duration to mimic the active procedure. Electrodes are placed on an ear location intended to minimize vagal activation (e.g., ear lobule), and stimulation is delivered at a minimal/low level to provide a similar sensation without therapeutic vagal stimulation. Pre- and post-session spirometry and other measurements are collected identically to the active arm. | Device | Sham auricular stimulation (control) |
Primary outcome
Change in forced expiratory volume in 1 second (FEV1)
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Forced expiratory volume in 1 second (FEV1), reported in liters (L), will be measured immediately before and immediately after the intervention. The outcome will be defined as the pre-to-post change (post minus pre), and between-group differences in change between active stimulation and sham control will be evaluated.[FVC], and peak expiratory flow [PEF]) will be measured immediately before and immediately after the intervention. The primary endpoint is the pre-to-post change (post minus pre) and the between-group difference in change between active stimulation and sham control.
Change in forced vital capacity (FVC)
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Forced vital capacity (FVC), reported in liters (L), will be measured immediately before and immediately after the intervention. The outcome will be defined as the pre-to-post change (post minus pre), and between-group differences in change between active stimulation and sham control will be evaluated.
Change in peak expiratory flow (PEF)
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Peak expiratory flow (PEF), reported in liters per minute (L/min), will be measured immediately before and immediately after the intervention. The outcome will be defined as the pre-to-post change (post minus pre), and between-group differences in change between active stimulation and sham control will be evaluated.
8 secondary outcomes
Change in RMSSD from chest recordings
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in SDNN from chest recordings
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in LF power from chest recordings
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in HF power from chest recordings
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in LF/HF ratio from chest recordings
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in systolic blood pressure (SBP)
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in diastolic blood pressure (DBP)
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Change in heart rate
Time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 30941526Paleczny B, Seredynski R, Ponikowska B. Inspiratory- and expiratory-gated transcutaneous vagus nerve stimulation have different effects on heart rate in healthy subjects: preliminary results. Clin Auton Res. 2021 Apr;31(2):205-214. doi: 10.1007/s10286-019-00604-0. Epub 2019 Apr 2.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 18839484Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
- Background: PubMed 27330520Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31.
- Background: PubMed 8598068Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Background: PubMed 36543841Kim AY, Marduy A, de Melo PS, Gianlorenco AC, Kim CK, Choi H, Song JJ, Fregni F. Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Sci Rep. 2022 Dec 21;12(1):22055. doi: 10.1038/s41598-022-25864-1.
- Background: PubMed 34937487Wang L, Wang Y, Wang Y, Wang F, Zhang J, Li S, Wu M, Li L, Rong P. Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Expert Rev Med Devices. 2022 Jan;19(1):43-61. doi: 10.1080/17434440.2022.2020095. Epub 2022 Jan 13.
- Background: PubMed 38729100Zou N, Zhou Q, Zhang Y, Xin C, Wang Y, Claire-Marie R, Rong P, Gao G, Li S. Transcutaneous auricular vagus nerve stimulation as a novel therapy connecting the central and peripheral systems: a review. Int J Surg. 2024 Aug 1;110(8):4993-5006. doi: 10.1097/JS9.0000000000001592.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared at this time. Study results will be reported in the manuscript in aggregated form. De-identified IPD may be made available upon reasonable request by contacting the corresponding author, subject to appropriate ethical and institutional approvals and data-use conditions.
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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.
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 in people with Vagus Nerve Stimulations and Spirometry, run by SEFA HAKTAN HATIK 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEFA HAKTAN HATIK, MSc, PhD (+90 368 271 55 28 ext. 4601, haktanhtk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forced expiratory volume in 1 second (FEV1) (time frame: Single visit: assessed pre-intervention and immediately post-intervention (within the same session).). The study lists 3 primary outcomes in all. 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 NCT07482930, which also lists 8 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 19 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.