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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05436821
Other study ID # 12068451746
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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