The Effect of Auricular Vagus Nerve Stimulation and Controlled Breathing Exercises on Performance and Autonomic Nervous System

NCT06796101 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-12-09

No results posted yet for this study

Summary

There are many studies in the literature on transcutaneous vagus nerve stimulation (VNS) and controlled breathing exercises (CBE), but there are limited studies examining the effects of both interventions on performance and the autonomic nervous system.

The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.

Conditions

  • Health People
  • Physical Activity
  • Autonomic Nerveus System
  • Vagus Nerve Stimulations

Interventions

DEVICE

Vagus Nerve Stimulation

In the study, CE certified vagus nerve stimulation device Vagustim will be used. Transcutaneous auricular vagus nerve stimulation will be applied bilaterally. The stimulation pulse width is 300 microseconds, frequency is 10 Hz and will be applied biphasically for 20 minutes.

OTHER

Controlled breathing exercises

A controlled breathing exercise group will continue for a total of 2 weeks and will receive 10 sessions of 20 minutes per day. The thoracic expansion exercise will be performed in 10 repetitions. In each intervention session, 2 sets of nadi shodhana pranayama consisting of 8 respiratory cycles will be applied to the patients, with a 2-minute rest period between the sets. Kapalabhati will be practised for 3 minutes, with 15 quick breaths in 10 seconds followed by a 20-second break (a total of 30 breaths per minute). In each session, 2 sets of bhramari pranayama consisting of 10 breathing cycles will be performed at a low respiratory rate, with a 1-minute rest period between sets. The physiological sigh exercise involves the first inspiration phase being 1 second, the second phase 0.25 seconds, and the exhalation 2 seconds for 3 minutes.

Sponsors & Collaborators

  • Bahçeşehir University

    lead OTHER

Principal Investigators

  • Okan ŞAHİN, PT, MSc · Bahçeşehir University

  • Ali Veysel ÖZDEN, MD, PHD · Bahçeşehir University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2025-11-21
Completion
2025-12-05

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06796101 on ClinicalTrials.gov