NCT07482930

Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial

Acute Effects Transcutaneous Auricular Vagus Nerve Stimulation on Spirometric Parameters in Healthy Individuals: A Sham-Controlled Randomized Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: SEFA HAKTAN HATIK · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Vagus Nerve Stimulations
• Spirometry
• Autonomic Nervous System (ANS) Functioning and Mood State
• Blood Pressure Monitoring
• Respiratory Function Tests

Interventions

Type	Name	Description
DEVICE	Transcutaneous auricular vagus nerve stimulation	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.
DEVICE	Sham transcutaneous auricular stimulation	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.

Timeline

• Start date: 2026-03-17
• Primary completion: 2026-04-20
• Completion: 2026-04-25
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Turkey (Türkiye)