Clinical Trials Directory

Trials / Completed

CompletedNCT06796101

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Bahçeşehir University · Academic / Other
Sex
Male
Age
18 Years – 35 Years
Healthy volunteers
Accepted

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.

Detailed description

The sympathetic and parasympathetic divisions of the autonomic nervous system affect the function of many organs, glands, and involuntary muscles in the body. The sympathetic and parasympathetic nervous systems often play opposing roles in the body, one is suppressed when the other increases activity. With the beginning of exercise or sports activity, sympathetic activity in the body increases and after a certain period reaches a plateau value at maximum activity. With the end of sports activity, the suppressed parasympathetic activity increases, and the sympathetic system returns to its resting state over time. Low sympathetic activity and/or high parasympathetic activity and low heart rate before training or exercise can be considered as performance indicators. It also indicates that recovery from the previous training or exercise is adequate. Parasympathetic system activation continues for up to 48 hours after exercise. If the exercise is intense and persistent, parasympathetic system activity can last up to 72 hours. In addition, due to the increase in anaerobic respiratory rate during exercise, there may be decreases in parasympathetic reactivation. Transcutaneous vagus nerve stimulation (VNS) can affect cardiovascular parameters both at rest and during exercise. VNS improves autonomic modulation and positively reduces pain and fatigue associated with cycling exercise. On the other hand, VNS is particularly useful in reducing pain and fatigue during and after competition. Slow breathing modulates the activity of the vagus nerve. Controlled breathing exercises (CBE) directly affect the respiratory rate, which can lead to faster physiological and psychological calming effects by increasing vagal tone during slow expiration. CBE increase heart rate variability in healthy participants. 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

Interventions

TypeNameDescription
DEVICEVagus Nerve StimulationIn 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.
OTHERControlled breathing exercisesA 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.

Timeline

Start date
2025-07-09
Primary completion
2025-11-21
Completion
2025-12-05
First posted
2025-01-28
Last updated
2025-12-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06796101. Inclusion in this directory is not an endorsement.