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

NCT06796101 | Completed

• 1 other identifier: ODRP-2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transcutaneous vagus nerve stimulation; Performance; Controlled breathing exercises; Autonomic nervous system; recreactional

Outcome Measures

Primary Outcomes (2)

• Performance

  Individuals will be taken to the treadmill and the distance and time taken until the maximum heart rate value reaches 80% will be recorded. The maximum heart rate value will be determined for each individual according to the formula 220-age. The participants will walk at a speed of 2 km/h for 1 minute, at a speed of 4 km/h for 1 minute and at a speed of 6 km/h, and the distance and time taken until the maximum heart rate reaches 80% will be recorded. In the termination phase of the run, a walk will be performed at a speed of 4 km/h for 1 minute and a speed of 2 km/h for 1 minute and will be completed.

  Baseline and 2 weeks.

• Autonomic nervous system

  Heart rate change will be evaluated for the evaluation of the autonomic nervous system. Polar H9 heart rate sensor chest strap and wristwatch will be used to measure analytical heart rate change. During the assessment, the participant will be seated in a chair and the Polar system chest strap will be placed just above the sternum, and ultrasound gel will be used to increase the sensor's conductivity. This method is valid with an electrocardiogram. Heart rate variability parameters such as RMSSD, LF, and HF will be measured.

  Baseline and 2 weeks.

Secondary Outcomes (6)

• International Physical Activity Questionnaire

  Baseline

• Modified Borg Scale

  Baseline and 2 weeks.

• Perceived Stress Scale

  Baseline and 2 weeks.

• Blood Pressure Measurement

  Baseline and 2 weeks.

• Pulse

  Baseline and 2 weeks.

Study Arms (2)

Transcutaneus vagus nerve stimulation

EXPERIMENTAL

This group will receive Transcutaneous vagus nerve stimulation from bilateral ear for two weeks, 10 sessions.

Device: Vagus Nerve Stimulation

Controlled breathing exercise group

EXPERIMENTAL

Controlled breathing exercises include thoracic expansion exercises, Nadi Shodhana Pranayama, Bhramari Pranayama, Kapalabhati and Physiological-sighing exercises.

Other: Controlled breathing exercises

Interventions

Vagus Nerve Stimulation DEVICE

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.

Transcutaneus vagus nerve stimulation

Controlled breathing exercises OTHER

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.

Controlled breathing exercise group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals with a moderate level of physical activity according to the International Physical Activity Scale
• No orthopedic obstacle to exertion
• Being male

You may not qualify if:

• Having any active or chronic disease
• Having cooperation problems
• Using regular medication for any chronic condition within the last year
• Being a smoker
• Having had heart surgery
• Having had surgery on the respiratory system

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahçesehir University

Istanbul, Istanbul, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Okan ŞAHİN, PT, MSc

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

• Ali Veysel ÖZDEN, MD, PHD

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT (Physiotherapist), MSc

Model Details: Individuals who are moderately physically active according to the physical activity scale between the ages of 18-35 who met the inclusion criteria will be included in the study. The sample size of the study is calculated as 64 and randomized to vagus stimulation and controlled breathing exercise groups. All evaluations of the participants will be held at Bahçeşehir University Faculty of Health Sciences Biomechanics chiropractic laboratory.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 28, 2025
• Study Start: July 9, 2025
• Primary Completion: November 21, 2025
• Study Completion: December 5, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)