The Effect of Vagus Nerve Stimulation on Sportive Performance.

Sports Performance Clinical Trial

Official title:

INVESTIGATION OF THE EFFECT OF NONINVASIVE AURICULAR VAGUS NERVE STIMULATION ON PERFORMANCE IN PROFESSIONAL ATHLETES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05436821
• Other study ID #: 12068451746
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2022
• Source: Ahi Evran University Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sports Performance

Intervention

Device:
• Auricular vagus nerve stimulation
Autonomic nerve system regulation
• Sham Auricular Vagus Nerve Stimulation (AVNS)
Sham Auricular Vagus Nerve Stimulation (AVNS)

Locations

Country	Name	City	State
Turkey	Kirsehir ahi Evran Üniversitesi	Kirsehir	Central Anatolia

Sponsors (1)

Lead Sponsor	Collaborator
ISMAIL CEYLAN

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendín 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate variability was controlled for autonomic measurement evaluation in both groups. Polar H7 heart rate sensor chest strap and wrist watch were used to measure analytical heart rate variability.	1 day