The Effect of Vagus Nerve Stimulation on Sportive Performance.

NCT ID: NCT05436821

Last Updated: 2022-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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.

Conditions

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Sports Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Auricular vagus nerve stimulation

Intervention Type DEVICE

Autonomic nerve system regulation

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.

Group Type SHAM_COMPARATOR

Sham Auricular Vagus Nerve Stimulation (AVNS)

Intervention Type DEVICE

Sham Auricular Vagus Nerve Stimulation (AVNS)

Interventions

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Auricular vagus nerve stimulation

Autonomic nerve system regulation

Intervention Type DEVICE

Sham Auricular Vagus Nerve Stimulation (AVNS)

Sham Auricular Vagus Nerve Stimulation (AVNS)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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İSMAİL CEYLAN

OTHER

Sponsor Role lead

Responsible Party

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İSMAİL CEYLAN

Head of hand therapy clinic. PhD.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Adem Çalı, PhD

Role: PRINCIPAL_INVESTIGATOR

Bahçeşehir University

Locations

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Kırşehir ahi Evran Üniversitesi

Kırşehir, Central Anatolia, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30307636 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38146234 (View on PubMed)

Other Identifiers

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12068451746

Identifier Type: -

Identifier Source: org_study_id

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