RecruitingNot ApplicableNCT07482930

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


Sponsor

SEFA HAKTAN HATIK

Enrollment

50 participants

Start Date

Mar 17, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • Aged 18-40 years.
  • Healthy volunteers.
  • Able to perform spirometry and follow study instructions.
  • Provided written informed consent.

Exclusion Criteria10

  • 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.
  • 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.

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Interventions

DEVICETranscutaneous 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.

DEVICESham 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.


Locations(1)

Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, 57900, Türkeli, Sinop, Türkiye

Sinop, Turkey (Türkiye)

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NCT07482930


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