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Completed

NCT Number: NCT06566118

Effects of Transcutaneous Vagus Nerve Stimulation on Recovery

During the recovery process, the activity of the sympathetic system decreases, while the activity of the parasympathetic system increases. In line with this information, the nervous system can be regulated in a noninvasive and practical way by using transcutaneous auricular vagus nerve stimulation in order to achieve rapid recovery in the athlete after the activity.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Recovery, Psychological Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Gelisim University

Istanbul, 34310, Turkey (Türkiye)

About this study

In sports where physical loads are high, athletes can usually participate in more than one training or race during the day. Such work increases the athlete's fatigue, affects their performance and can cause serious declines. Therefore, an efficient and effective recovery process after high-intensity work and training that causes a decrease in performance is also very important for the athlete's next performance.

With the start of sports activity or exercise, sympathetic activation in the body increases and after a while reaches a plateau value at maximum activity. With the end of exercise, this time the suppressed parasympathetic activity begins to increase and the sympathetic system returns to a resting state over time.

There are insufficient studies in the literature investigating the use of Transcutaneous Auricular Vagus Nerve Stimulation on the athletic population. Although it is clear that the application has effects on the sympathetic and parasympathetic nervous systems, more clinical research is needed on athletes. In this study, we aimed to investigate the effects of auricular vagus nerve stimulation (VNS) on vagal activity by examining the effect of transcutaneous auricular vagus nerve stimulation on recovery in amateur athletes through applications such as pulse and SpO2, blood pressure, perceived fatigue, and respiratory function tests.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being healthy between the ages of 18-25,
  • Volunteering to participate in the study,
  • Signing the voluntary consent form,
  • Being an amateur football player who continues his/her active sports life,
  • Not having an injury that prevents participation in the study.

Exclusion criteria

  • Having a disease related to the respiratory system,
  • Having a disease related to the cardiac system,
  • Having any chronic disease and using a medication related to it.

Treatment and study plan

Auricular Vagus Nerve Stimülation

Device

After exercise loading, active ear VSS was applied to Group 1. Application was made simultaneously in both ears, with a 300 microsecond pulse duration, a biphasic asymmetric waveform, and a frequency of 25 Hz, for a total of 20 minutes. All assessments were recorded 3 times: at the beginning of the test, after exercise loading, and after active VSS application.

Sham Auricular Vagus Nerve Stimülation

Device

After the exercise challenge, Group 2 underwent sham VSS. Device parameters were set to the same as Group 1 (300 microsecond pulse duration, biphasic asymmetric waveform, and 25 Hz frequency). Both headphones were worn for a total of 20 minutes. However, the participant heard only the device's power-on tone and received no current. All assessments were recorded three times: at the beginning of the test, after the exercise challenge, and after sham VSS.

Primary outcomes

  1. Respiratory Function Test

    Time frame: 2 Months

    In our study, FVC measurement were calculated using a MiniSpir2 brand spirometer device. The measurements were performed while the participants were sitting in a fixed chair. The measurements were repeated 3 times for each participant and the two highest values read on the device were recorded as an average.

  2. Respiratory Function Test

    Time frame: 2 Months

    In our study, FEV1/FVC measurement were calculated using a MiniSpir2 brand spirometer device. The measurements were performed while the participants were sitting in a fixed chair. The measurements were repeated 3 times for each participant and the two highest values read on the device were recorded as an average.

  3. Respiratory Function Test

    Time frame: 2 Months

    In our study, PEF measurement were calculated using a MiniSpir2 brand spirometer device. The measurements were performed while the participants were sitting in a fixed chair. The measurements were repeated 3 times for each participant and the two highest values read on the device were recorded as an average.

  4. Respiratory Function Test

    Time frame: 2 Months

    In our study, FEV1 measurement were calculated using a MiniSpir2 brand spirometer device. The measurements were performed while the participants were sitting in a fixed chair. The measurements were repeated 3 times for each participant and the two highest values read on the device were recorded as an average.

Secondary outcomes

  1. BORG Perceived Fatigue Measurement

    Time frame: 2 Months

    The Borg Perceived Fatigue Scale was used to assess the degree of fatigue perceived by the participants. BORG is a scale developed to assess the level of strain experienced by individuals during physical activities. This scale is based on physical measures such as respiratory rate, heart rate, muscle fatigue and sweating perceived by individuals during physical exertion. The scale is scored between 6 and 20. If the participant's perceived muscle fatigue is very mild, a score of 9 is given. Scores between 12 and 14 on BORG indicate that the exertion is moderate. If the individual perceives that they are exerting very much, a score of 19 is given.

Other outcomes

  1. Pulse Measurement

    Time frame: 2 Months

    Endostall Pulse Oximeter device was used to measure the participants' pulse values.

  2. SPO2 Measurement

    Time frame: 2 Months

    Endostall Pulse Oximeter device was used to measure the participants' SPO2 values.

  3. Blood Pressure Measurement

    Time frame: 2 Months

    Systolic and diastolic blood pressures of all participants were measured using an Omron M6 AC HEM-7322-E arm blood pressure monitor.

Sponsors and collaborators

Lead sponsor

Istanbul Gelisim University

Other

Registry information

Official study title

Effects of Transcutaneous Vagus Nerve Stimulation on Recovery After Sports Activity in Young Athletes

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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