Sports PerformanceNCT05436821
The Effect of Vagus Nerve Stimulation on Sportive Performance.
A study testing Auricular vagus nerve stimulation in people with Sports Performance, run by İSMAİL CEYLAN at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Performance
- What is being tested?
- Auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 May 2022
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir ahi Evran Üniversitesi
Kırşehir, Central Anatolia
About this study
Official title: INVESTIGATION OF THE EFFECT OF NONINVASIVE AURICULAR VAGUS NERVE STIMULATION ON PERFORMANCE IN PROFESSIONAL ATHLETES
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.
Read the detailed 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.
- Conditions
- Sports Performance
- Being tested
- Auricular vagus nerve stimulation, Sham Auricular Vagus Nerve Stimulation (AVNS)
- Keywords
- Vagus, autonomic nerve system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular vagus nerve stimulationDevice
Autonomic nerve system regulation
Sham Auricular Vagus Nerve Stimulation (AVNS)Device
Sham Auricular Vagus Nerve Stimulation (AVNS)
| Study group | Role | What they receive |
|---|---|---|
| Vagus nerve stimulation | Experimental | Auricular Vagus Nerve Stimulation (AVNS) was applied to the experimental group. AVNS application was applied to both ears simultaneously for 20 minutes, with waveform biphasic asymmetric, pulse duration 300 microseconds and frequency 25 hertz. AVNS application was made with Vagustim brand device.
The acute effect of the application was evaluated in both groups by isometric quadriceps strength measurement, heart rate variability measurement, grip strength measurement and modified star balance test measurement performed before and after the single session AVNS. Receives: Device: Auricular vagus nerve stimulation |
| Control group | Sham comparator | Sham Auricular Vagus Nerve Stimulation (AVNS) was applied to the experimental group. AVNS application was applied to both ears simultaneously for 20 minutes, with no pulse. AVNS application was made with Vagustim brand device.
Before and after sham AVNS isometric quadriceps strength measurement, heart rate variability measurement, grip strength measurement and modified star balance test measurement performed. Receives: Device: Sham Auricular Vagus Nerve Stimulation (AVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Sep 2021
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sports PerformanceStudies 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
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- İSMAİL CEYLAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İSMAİL CEYLAN, Ahi Evran University Education and Research Hospital
- Investigators
- Adem Çalı, PhD, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436821
- Sponsor's protocol ID
- 12068451746
- Status last verified
- Jun 2022
- First submitted
- 24 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendin 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.
PubMed 30307636Caliota A, Ozden AV, Ceylan I. Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial. Expert Rev Med Devices. 2024 Mar;21(3):231-237. doi: 10.1080/17434440.2023.2299300. Epub 2023 Dec 30.
PubMed 38146234
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF THE EFFECT OF NONINVASIVE AURICULAR VAGUS NERVE STIMULATION ON PERFORMANCE IN PROFESSIONAL ATHLETES
- ClinicalTrials.gov ID
- NCT05436821
- Acronym / sponsor ID
- 12068451746
- Conditions
- Sports Performance
- Keywords
- Vagus, autonomic nerve system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- İSMAİL CEYLANUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 29 Jun 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve stimulation | Experimental | Device: Auricular vagus nerve stimulationAuricular Vagus Nerve Stimulation (AVNS) was applied to the experimental group. AVNS application was applied to both ears simultaneously for 20 minutes, with waveform biphasic asymmetric, pulse duration 300 microseconds and frequency 25 hertz. AVNS application was made with Vagustim brand device. The acute effect of the application was evaluated in both groups by isometric quadriceps strength measurement, heart rate variability measurement, grip strength measurement and modified star balance test measurement performed before and after the single session AVNS. |
| Control group | Sham comparator | Device: Sham Auricular Vagus Nerve Stimulation (AVNS)Sham Auricular Vagus Nerve Stimulation (AVNS) was applied to the experimental group. AVNS application was applied to both ears simultaneously for 20 minutes, with no pulse. AVNS application was made with Vagustim brand device. Before and after sham AVNS isometric quadriceps strength measurement, heart rate variability measurement, grip strength measurement and modified star balance test measurement performed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 stimulationAutonomic nerve system regulation | Device | Vagus nerve stimulation |
| Sham Auricular Vagus Nerve Stimulation (AVNS)Sham Auricular Vagus Nerve Stimulation (AVNS) | Device | Control group |
Primary outcome
Heart rate
Time frame: 1 day
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.
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 29 Jun 2022.
- Background: PubMed 30307636Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendin 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.
- Derived from this study: PubMed 38146234Caliota A, Ozden AV, Ceylan I. Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial. Expert Rev Med Devices. 2024 Mar;21(3):231-237. doi: 10.1080/17434440.2023.2299300. Epub 2023 Dec 30.
- 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.
Adem Çalı, PhD principal investigator
Bahçeşehir University
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 stimulation in people with Sports Performance, run by İSMAİL CEYLAN 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 3 inclusion and 4 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 29 Jun 2022. 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?
Heart rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436821, which also lists 2 linked publications.
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 29 Jun 2022.