Clinical trial NCT05436821: The Effect of Vagus Nerve Stimulation on Sportive Performance.
Official title: INVESTIGATION OF THE EFFECT OF NONINVASIVE AURICULAR VAGUS NERVE STIMULATION ON PERFORMANCE IN PROFESSIONAL ATHLETES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Performance
Keywords: Vagus, autonomic nerve system
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Performance is defined as the physiological potential required for an individual's physical activity. The sportive activity that he creates with his potential is defined as the sportive performance level of the individual. There are many factors that determine athletic performance. These factors are; environmental factors such as heredity, physical structure, training level, technical capacity and mental adequacy, quality of training areas, nutritional quality, suitability in weather conditions. All these factors affect the planning of multidisciplinary and interdisciplinary approaches that affect the performance of the athlete.

Autonomic regulation is very important for the reorganization of the athlete's performance. Auricular vagus nerve stimulation (VNS) is a non-invasive method. With this method, autonomic nervous system regulation can be done practically. In the literature, there are no studies examining the effect of VNS on recovery and performance in athletes.

Detailed description: In this study, the effects of auricular vagus nerve stimulation on performance and recovery were investigated, which was designed as a randomized controlled trial, a single session of VSU was applied to 60 male professional athletes (30 experimantal, 30 control). The normal application waveform was biphasic asymmetric, with a pulse duration of 300 microseconds and a frequency of 25 hertz, for 20 minutes and continuously.

Eligibility criteria: Inclusion Criteria:

* Being an athlete who continues an active sports life.
* Not have an ongoing injury that prevents participation in the study
* To make a medium and high level weekly training period.

Exclusion Criteria:

* Having a systemic or neurological disease affecting the autonomic nervous system.
* Be younger than 18 years old and over 40 years old.
* Loss of sensation affecting the inner and outer ear, etc. have the disease.
* Having any acute systemic disease to exercise.

Primary outcomes:
measure: Heart rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir ahi Evran Üniversitesi
state: Central Anatolia
Study officials:
affiliation: Bahçeşehir University
name: Adem Çalı, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendin F. Effectiveness of mobilisation of the upper cervical region and craniocervical flexor training on orofacial pain, mandibular function and headache in women with TMD. A randomised, controlled trial. J Oral Rehabil. 2019 Feb;46(2):109-119. doi: 10.1111/joor.12733. Epub 2018 Oct 26.