The Effect of Vagus Nerve Stimulation on Sportive Performance.

NCT05436821 | Completed DMC

• 1 other identifier: 12068451746
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sports Performance

Keywords

Vagus, autonomic nerve system

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vagus nerve stimulation

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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)

Interventions

Auricular vagus nerve stimulation DEVICE

Autonomic nerve system regulation

Vagus nerve stimulation

Sham Auricular Vagus Nerve Stimulation (AVNS) DEVICE

Sham Auricular Vagus Nerve Stimulation (AVNS)

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: 60 people between the ages of 18-40, who applied to the Orthopedics and Traumatology Department of Private Ataşehir Florence Nightingale Hospital, performed pre-mid-end performance training, completed rehabilitation after injury, continued active sports life, and had moderate and high training tempo. male professional athlete.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• İSMAİL CEYLAN: lead

Study Sites (1)

Kırşehir ahi Evran Üniversitesi

Kırşehir, Central Anatolia, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30307636 BACKGROUND

• Caliota A, Ozden AV, Ceylan I. Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial. Expert Rev Med Devices. 2024 Mar;21(3):231-237. doi: 10.1080/17434440.2023.2299300. Epub 2023 Dec 30.

  PMID: 38146234 DERIVED

Study Officials

• Adem Çalı, PhD

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of hand therapy clinic. PhD.

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: September 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)