Effects of Transcutaneous Vagus Nerve Stimulation on Recovery

NCT ID: NCT06566118

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-09-15

Brief Summary

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.

Detailed Description

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.

Conditions

Fatigue; Recovery, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Active auricular VSS was applied to the participants in Group 1 after exercise loading.

Group Type: EXPERIMENTAL

Auricular Vagus Nerve Stimülation

Intervention Type: 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 Group

Sham auricular VSS was applied to the participants in Group 2. During the application, the device was shown to the participants while it was being operated, but no current was given to the participants because non-conductive headphones were used.

Group Type: SHAM_COMPARATOR

Sham Auricular Vagus Nerve Stimülation

Intervention Type: 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.

Interventions

Auricular Vagus Nerve Stimülation

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.

Intervention Type: DEVICE

Sham Auricular Vagus Nerve Stimülation

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Gelisim University

OTHER

Sponsor Role: lead

Responsible Party

Ali Karaağaç

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ALİ KARAAĞAÇ, MSc

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

İstanbul Gelisim University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

ALİ KARAAĞAÇ, MSc

Role: CONTACT

akaraagac@gelisim.edu.tr

05437290968

Facility Contacts

ALİ KARAAĞAÇ, MSc

Role: primary

akaraagac@gelisim.edu.tr

05437290968

Other Identifiers

IGU-FTR-AK-01

Identifier Type: -

Identifier Source: org_study_id