The Effect of Vagus Nerve Stimulation on Sportive Performance.

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

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.

Study Overview

• Status: Completed
• Conditions: Sports Performance
• Intervention / Treatment: Device: Auricular vagus nerve stimulation; Device: Sham Auricular Vagus Nerve Stimulation (AVNS)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Central Anatolia
    • Kırşehir, Central Anatolia, Turkey
      • Kırşehir Ahi Evran Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vagus nerve stimulation; Auricular Vagus Nerve Stimulation (AVNS) was applied to the experimental group. AVNS application was applied to both ears simultaneously for 20 minutes, with waveform biphasic asymmetric, pulse duration 300 microseconds and frequency 25 hertz. AVNS application was made with Vagustim brand device. The acute effect of the application was evaluated in both groups by isometric quadriceps strength measurement, heart rate variability measurement, grip strength measurement and modified star balance test measurement performed before and after the single session AVNS.	Device: Auricular vagus nerve stimulation; Autonomic nerve system regulation
SHAM_COMPARATOR: Control group; Sham Auricular Vagus Nerve Stimulation (AVNS) was applied to the experimental group. AVNS application was applied to both ears simultaneously for 20 minutes, with no pulse. AVNS application was made with Vagustim brand device. Before and after sham AVNS isometric quadriceps strength measurement, heart rate variability measurement, grip strength measurement and modified star balance test measurement performed.	Device: Sham Auricular Vagus Nerve Stimulation (AVNS); Sham Auricular Vagus Nerve Stimulation (AVNS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: İSMAİL CEYLAN
• Investigators: Principal Investigator: Adem Çalı, PhD, Bahcesehir university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): April 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (ACTUAL): June 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Vagus, autonomic nerve system
• Other Study ID Numbers: 12068451746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No