Ear (auricular) vagus nerve stimulation to see if a short session changes breathing test results
Acute Effects Transcutaneous Auricular Vagus Nerve Stimulation on Spirometric Parameters in Healthy Individuals: A Sham-Controlled Randomized Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Sinop University Academic / other |
| Locations | 1 site (Sinop) |
| Trial ID | NCT07482930 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18–40 who can perform spirometry and have no cardiovascular, neurological, psychiatric, or respiratory diagnoses.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sinop
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.