FatigueNCT06566118
Effects of Transcutaneous Vagus Nerve Stimulation on Recovery
A study testing Auricular Vagus Nerve Stimülation in people with Fatigue and Recovery, Psychological, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Recovery, Psychological
- What is being tested?
- Auricular Vagus Nerve Stimülation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Gelisim University
Istanbul, Istanbul, 34310
About this study
Official title: Effects of Transcutaneous Vagus Nerve Stimulation on Recovery After Sports Activity in Young Athletes
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.
Read the 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
- Being tested
- Auricular Vagus Nerve Stimülation, Sham Auricular Vagus Nerve Stimülation
- Keywords
- Auricular Vagus Nerve Stimulation, Athlete, Recovery
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Vagus Nerve StimülationDevice
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 StimülationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Active auricular VSS was applied to the participants in Group 1 after exercise loading. Receives: 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. Receives: Device: Sham Auricular Vagus Nerve Stimülation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 Months
Secondary outcomes (1)
BORG Perceived Fatigue Measurement
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.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Aug 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Uncontrolled study with the same sample in two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Karaağaç, Istanbul Gelisim University
- Investigators
- ALİ KARAAĞAÇ, MSc, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566118
- Sponsor's protocol ID
- IGU-FTR-AK-01
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Vagus Nerve Stimulation on Recovery After Sports Activity in Young Athletes
- ClinicalTrials.gov ID
- NCT06566118
- Acronym / sponsor ID
- IGU-FTR-AK-01
- Conditions
- Fatigue, Recovery, Psychological
- Keywords
- Auricular Vagus Nerve Stimulation, Athlete, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Uncontrolled study with the same sample in two groups
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Auricular Vagus Nerve StimülationActive auricular VSS was applied to the participants in Group 1 after exercise loading. |
| Sham Group | Sham comparator | Device: Sham Auricular Vagus Nerve StimülationSham 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Vagus Nerve StimülationAfter 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. | Device | Intervention Group |
| Sham Auricular Vagus Nerve StimülationAfter 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. | Device | Sham Group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
BORG Perceived Fatigue Measurement
Time frame: 2 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALİ KARAAĞAÇ, MSc principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Vagus Nerve Stimülation in people with Fatigue and Recovery, Psychological, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Function Test (time frame: 2 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.