Ear (auricular) vagus nerve stimulation to see if a short session changes breathing test results
Official title: Acute Effects Transcutaneous Auricular Vagus Nerve Stimulation on Spirometric Parameters in Healthy Individuals: A Sham-Controlled Randomized Study
Run by Sinop University · NCT07482930 · Data updated 2026-11-12
This will test whether a brief, non-invasive electrical stimulation of the outer ear changes spirometry (breathing) measurements in healthy adults aged 18–40.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Sinop University Academic / other |
| Locations | 1 site (Sinop) |
| Status | Recruiting |
| Started | March 17, 2026 |
| Main results expected | April 20, 2026 |
| Study ends | April 25, 2026 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07482930 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults aged 18–40 who can perform spirometry and have no cardiovascular, neurological, psychiatric, or respiratory diagnoses.
✕Probably not a fit
People with existing heart, lung, neurological, or psychiatric disorders, pregnant individuals, those with ear conditions or piercings at the stimulation site, or anyone intolerant of the device are unlikely to benefit from this short-session test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Healthy volunteers attend a single lab visit and are randomly assigned to either active bilateral transcutaneous auricular vagus nerve stimulation (taVNS) or a sham procedure that mimics the device experience. Stimulation lasts about 10 minutes with intensity adjusted individually, and standard spirometry is measured immediately before and after the session. The trial is sham-controlled, single-blind, and parallel-group to reduce expectancy effects, with concealed randomization and identical device appearance across groups. The primary goal is to determine whether a single, short taVNS session produces measurable short-term changes in common pulmonary function parameters compared with sham.
Why it matters
Potential benefit: If successful, this could identify a simple, non-invasive way to change autonomic input to breathing and guide future research on therapeutic or monitoring applications.
How similar studies have gone: Previous studies have examined taVNS effects on autonomic and other physiological outcomes, but evidence for immediate spirometric changes in healthy people is limited and mixed.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, 57900, Türkeli, Sinop, Türkiye
Sinop, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: SEFA HAKTAN HATIK, MSc, PhD
- Email: haktanhtk@gmail.com
- Phone: +90 368 271 55 28
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.