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

RecruitingNAAges 18 Years - 40 YearsAllSEFA HAKTAN HATIK
NCT07482930 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18-40 years. * Healthy volunteers. * Able to perform spirometry and follow study instructions. * Provided written informed consent. Exclusion Criteria: * 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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What it tests

  • Transcutaneous auricular vagus nerve stimulation
  • Sham transcutaneous auricular stimulation
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Where

1 site
Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, 57900, Türkeli, Sinop, Türkiye
Sinop, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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