Effects of Transcutaneous Vagus Nerve Stimulation on Recovery

NCT06566118 | Completed

• 1 other identifier: IGU-FTR-AK-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Recovery, Psychological

Keywords

Auricular Vagus Nerve Stimulation; Athlete; Recovery

Outcome Measures

Primary Outcomes (4)

• Respiratory Function Test

  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 Months

• Respiratory Function Test

  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.

  2 Months

• Respiratory Function Test

  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.

  2 Months

• Respiratory Function Test

  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.

  2 Months

Secondary Outcomes (1)

• BORG Perceived Fatigue Measurement

  2 Months

Other Outcomes (3)

• Pulse Measurement

  2 Months

• SPO2 Measurement

  2 Months

• Blood Pressure Measurement

  2 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: Auricular Vagus Nerve Stimülation

Sham Group

SHAM COMPARATOR

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.

Device: Sham Auricular Vagus Nerve Stimülation

Interventions

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.

Intervention Group

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.

Sham Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Gelisim University: lead

Study Sites (1)

İstanbul Gelisim University

Istanbul, Istanbul, 34310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ALİ KARAAĞAÇ, MSc

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During the application to the group that would receive sham auricular vagus nerve stimulation, the device was shown to the participants while it was being operated, but no current was given to the participants because headphones without conductive properties were used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Uncontrolled study with the same sample in two groups

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 22, 2024
• Study Start: August 1, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)