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/30941526Actively Recruiting
Led by SEFA HAKTAN HATIK · Updated on 2026-03-19
50
Participants Needed
1
Research Sites
N/A
Total Duration
S
SEFA HAKTAN HATIK
Lead Sponsor
S
Sinop University
Collaborating Sponsor
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
Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
Total: 1 location
1
Güzelyurt Neighborhood, Mustafa Bozkurt Street, No: 9, 57900, Türkeli, Sinop, Türkiye
Sinop, Turkey (Türkiye), 57900
Actively Recruiting
S
SEFA HAKTAN HATIK, MSc, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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