Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID07482930

Acute Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Lung Function Measured by Spirometry in Healthy Adults: A Sham-Controlled Randomized Study

Led by SEFA HAKTAN HATIK · Updated on 2026-03-19

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

SEFA HAKTAN HATIK

Lead Sponsor

S

Sinop University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the short-term effects of transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive electrical stimulation applied to the outer ear, on lung function in healthy adults aged 18 to 40. The vagus nerve influences many automatic body functions, and this study investigates whether a brief stimulation session can acutely alter breathing test results in people without respiratory disease. Participants are randomly assigned to one of two groups: active bilateral taVNS applied to ear regions connected to the vagus nerve, or a sham stimulation designed to mimic the procedure without activating the nerve. The stimulation lasts about 10 minutes during a single laboratory visit. Spirometry tests measuring forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF) are performed immediately before and after stimulation. Heart rate, heart rate variability, and blood pressure may also be recorded for safety and physiological monitoring. During the visit, participants undergo spirometry and physiological measurements before and after the stimulation session. Researchers monitor for any side effects, which are usually mild and temporary, such as tingling or slight discomfort in the ear. Participants may withdraw at any time. The main outcomes focus on changes in lung function measurements between pre- and post-stimulation. Data analysis will compare these changes between the active and sham groups to understand whether short-term ear-based vagus nerve stimulation influences breathing test results.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-40 years
  • Healthy volunteers without significant medical conditions
  • Able to perform spirometry and follow study instructions
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Any cardiovascular disease, cardiac arrhythmia, hypertension, or related condition
  • Any neurological disorder such as diabetes mellitus, peripheral neuropathy, or epilepsy
  • Any diagnosed psychiatric disorder
  • Any respiratory disease like asthma or chronic obstructive pulmonary disease
  • Pregnancy or suspected pregnancy
  • Ear conditions preventing stimulation, including infection, open wound, pain, tenderness, or ear piercings near 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 procedure
  • Inability to follow instructions during measurements or refusal to complete the session

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants undergo a single session of either active or sham transcutaneous auricular vagus nerve stimulation. The stimulation lasts approximately 10 minutes, with electrodes placed on specific ear regions depending on group assignment. Spirometry and physiological measurements are taken immediately before and after the stimulation within the same visit.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

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

Sinop, Turkey (Türkiye), 57900

Actively Recruiting

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Research Team

S

SEFA HAKTAN HATIK, MSc, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Inspiratory- and expiratory-gated transcutaneous vagus nerve stimulation have different effects on heart rate in healthy subjects: preliminary results.

Bartłomiej Paleczny, Rafał Seredyński, Beata Ponikowska

https://pubmed.ncbi.nlm.nih.gov/30941526

Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology.

https://pubmed.ncbi.nlm.nih.gov/8598068

Transcutaneous auricular vagus nerve stimulation as a novel therapy connecting the central and peripheral systems: a review.

Ningyi Zou, Qing Zhou, Yuzhengheng Zhang...

https://pubmed.ncbi.nlm.nih.gov/38729100