HealthyVNS001NCT04768738
The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters
A study testing Auricular Vagus Nerve Stimulation Level Of Above Threshold, Auricular Vagus Nerve Stimulation Level Of Subthreshold and 5 Minutes Bicycle Exercise in people with Healthy and Activity, Motor, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
OBJECTIVE: The aim of this study is to investigate the effect of non-invasive auricular VNS (Vagus Nerve Stimulation) on sportive performance and physiological parameters in healthy individuals. MATERIAL AND METHOD: 46 healthy young individuals aged 19.2(±1.5) years participated in the study. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Activity, Motor
- What is being tested?
- Auricular Vagus Nerve Stimulation Level Of Above Threshold, Auricular Vagus Nerve Stimulation Level Of Subthreshold and 5 Minutes Bicycle Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Nov 2020
- 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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years age
- Being healthy
Who cannot join
- any known disease
- any drug usage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters In Healthy Young Individuals: Randomized, Double-Blind Study
OBJECTIVE: The aim of this study is to investigate the effect of non-invasive auricular VNS (Vagus Nerve Stimulation) on sportive performance and physiological parameters in healthy individuals.
MATERIAL AND METHOD: 46 healthy young individuals aged 19.2(±1.5) years participated in the study. The participants were randomly divided into 3 groups as Above Threshold Group (n:15; 10 females, 5 males), Under Threshold Group (n:15; 10 females, 5 males) and Control Group (no stimulation) (n:16; 11 females, 5 males) according to the sensation of electrical current on ears. The participants were evaluated 3 times; before the application, after the first and second bicycle exercises. Numerical pain scale (NPS), pulse rate, blood pressure, respiratory rate, and distance travelled during exercise for sportive performance were recorded in kilometers as the evaluation method. The stimulation was done during the first bicycle exercise with 5 minutes of duration. The Kruskal-wallis, mann-whitney u test were used for the quantitative independent data obtained. In the analysis of qualitative independent data, chi-squared test was used.
Read the detailed description
This study included 46 individuals aged 18-35 years in the home patient care laboratory at Sinop University Vocational School of Turkeli. Priorities were explained and the permission of the individuals was obtained. The number of females and males was divided into 3 groups as randomized. Participants were evaluated by Numerical pain scale (NPS), pulse rate, blood pressure, respiratory rate, and saturation measurement. In addition, the distance travelled during the exercise for sportive performance was recorded in kilometers. In the study, evaluation was conducted 3 times before the application, after the first and second bicycle exercises.
The study was double-blind randomized. Participants in the whole group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes. In all groups Vagustim device was used for stimulation. In the above threshold group, biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes. VNS was applied bilaterally to transmit current from the tragus and concha parts of the ear. After the first bicycle exercise, the participants were re-evaluated. In the second bicycle exercise, it was asked to perform for 5 minutes under the same load without any application. The study was evaluated for the third time and the study was completed.
In the subthreshold group, the parameters were the same but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes. It was re-evaluated after the first bicycle exercise. In the second bicycle exercise, he was asked to perform bicycle exercise with maximum performance for 5 minutes under the same load without any application. The study was evaluated for the third time and the study was completed.
In the control group, bicycle exercise was performed under the same load with the current-free headset produced for sham applications for 5 minutes. Participants were shown that the device was working, but no current was given. It was re-evaluated after the first bicycle exercise. In the second bicycle exercise, the device was removed and asked to perform bicycle exercise with maximum performance for 5 minutes under the same load. The study was evaluated for the third time and the study was completed.
- Conditions
- Healthy, Activity, Motor
- Being tested
- Auricular Vagus Nerve Stimulation Level Of Above Threshold, Auricular Vagus Nerve Stimulation Level Of Subthreshold, Auricular Vagus Nerve Stimulation Sham Method, 5 Minutes Bicycle Exercise
- Keywords
- Transcutaneous auricular Vagus Nerve Stimulation, Sportive Performance, Physiological Parameters
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Vagus Nerve Stimulation Level Of Above ThresholdDevice
Biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes.
Auricular Vagus Nerve Stimulation Level Of SubthresholdDevice
Also called Level Of Subthreshold
biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The parameters were the same with Above Threshold Group but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes.
Auricular Vagus Nerve Stimulation Sham MethodDevice
Also called Sham Method
Participants were shown that the device was working, but no current was given.
5 Minutes Bicycle ExerciseDiagnostic test
Also called Bicycle Exercise
Participants in this group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Above Threshold Group | Experimental | In the above threshold group, biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes. Receives: Device: Auricular Vagus Nerve Stimulation Level Of Above Threshold; Diagnostic Test: 5 Minutes Bicycle Exercise |
| Subthreshold Group | Experimental | In the subthreshold group, biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The parameters were the same with Above Threshold Group but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes. Receives: Device: Auricular Vagus Nerve Stimulation Level Of Subthreshold; Diagnostic Test: 5 Minutes Bicycle Exercise |
| Control Group | Sham comparator | In the control group, bicycle exercise was performed under the same load with the current-free headset produced for sham applications for 5 minutes. Participants were shown that the device was working, but no current was given. Receives: Device: Auricular Vagus Nerve Stimulation Sham Method; Diagnostic Test: 5 Minutes Bicycle Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sportive performance
Athletic performance during exercise in healthy individuals, cycling length in kilometers. Measured twice, during first and second exercises.
Measured: Change from Baseline at Second Exercise
Secondary outcomes (11)
Pulse
Heart beats per minute. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: Change from Baseline at 5 minutes
Pulse
Heart beats per minute. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: 15 minutes
Numerical pain scale (NPS),
Amount of pain described by patients. Patients are asked to circle the number between 0 and 10. Zero represents 'no pain at all' whereas ten represents 'the worst pain ever possible'. Measurement is done twice; after the first and the second bicycle exercises.
Measured: Change from Baseline at 15 minutes
Respiratory Rate
The respiratory rate corresponds to the number of breaths taken per minute. The rate of respiration measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: Change from Baseline at 5 minutes
Respiratory Rate
The respiratory rate corresponds to the number of breaths taken per minute. The rate of respiration measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: 15 minutes
Systolic Blood Pressure
Systolic Pressure measured 3 times; before the first exercise, after the first exercise, after the second exercise. Blood pressure recorded as mmHg. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: Change from Baseline at 5 minutes
Systolic Blood Pressure
Systolic Pressure measured 3 times; before the first exercise, after the first exercise, after the second exercise. Blood pressure recorded as mmHg. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: 15 minutes
Diastolic Blood Pressure
Diastolic Pressure measured 3 times; before the first exercise, after the first exercise, after the second exercise. Blood pressure recorded as mmHg. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: Change from Baseline at 5 minutes
Diastolic Blood Pressure
Diastolic Pressure measured 3 times; before the first exercise, after the first exercise, after the second exercise. Blood pressure recorded as mmHg. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: 15 minutes
Saturation
Percentage of Oxygen saturation in blood. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: Change from Baseline at 5 minutes
Saturation
Percentage of Oxygen saturation in blood. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Feb 2020
- Primary completion1 Feb 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 46 healthy young individuals aged 19.2±1.5 years participated in the study. The participants were randomly divided into 3 groups as Above Threshold Group (n:15; 10 females, 5 males), Under Threshold Group (n:15; 10 females, 5 males) and Control Group (no stimulation) (n:16; 11 females, 5 males) according to the sensation of electrical current on ears. The participants were evaluated 3 times; before the application, after the first and second bicycle exercises. Numerical pain scale (NPS), pulse rate, blood pressure, respiratory rate, and distance travelled during exercise for sportive performance were recorded in kilometers as the evaluation method. The stimulation was done during the first bicycle exercise with 5 minutes of duration. The Kruskal-wallis, mann-whitney u test were used for the quantitative independent data obtained. In the analysis of qualitative independent data, chi-squared test was used.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEFA HAKTAN HATIK, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768738
- Sponsor's protocol ID
- VNS001
- Acronym
- VNS001
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nur Gökçe, E , Pınar Cengi̇z, Z , Erbaş, O . (2018). Uzun ömrün sırrı: Vagus siniri . İstanbul Bilim Üniversitesi Florence Nightingale Tıp Dergisi , 4 (3) , 154-165 . Retrieved from https://dergipark.org.tr/tr/pub/ibufntd/issue/39718/470405
Tracey, K.J., Inhibition of inflammatory cytokine production by cholinergic agonists and vagus nerve stimulation. 2003, Google Patents
Hong GS, Zillekens A, Schneiker B, Pantelis D, de Jonge WJ, Schaefer N, Kalff JC, Wehner S. Non-invasive transcutaneous auricular vagus nerve stimulation prevents postoperative ileus and endotoxemia in mice. Neurogastroenterol Motil. 2019 Mar;31(3):e13501. doi: 10.1111/nmo.13501. Epub 2018 Nov 8.
PubMed 30406957Liu JJ, Huang N, Lu Y, Zhao M, Yu XJ, Yang Y, Yang YH, Zang WJ. Improving vagal activity ameliorates cardiac fibrosis induced by angiotensin II: in vivo and in vitro. Sci Rep. 2015 Nov 24;5:17108. doi: 10.1038/srep17108.
PubMed 26596640Lataro RM, Silva CA, Fazan R Jr, Rossi MA, Prado CM, Godinho RO, Salgado HC. Increase in parasympathetic tone by pyridostigmine prevents ventricular dysfunction during the onset of heart failure. Am J Physiol Regul Integr Comp Physiol. 2013 Oct 15;305(8):R908-16. doi: 10.1152/ajpregu.00102.2013. Epub 2013 Aug 15.
PubMed 23948774Dalli J, Colas RA, Arnardottir H, Serhan CN. Vagal Regulation of Group 3 Innate Lymphoid Cells and the Immunoresolvent PCTR1 Controls Infection Resolution. Immunity. 2017 Jan 17;46(1):92-105. doi: 10.1016/j.immuni.2016.12.009. Epub 2017 Jan 5.
PubMed 28065837Penry JK, Dean JC. Prevention of intractable partial seizures by intermittent vagal stimulation in humans: preliminary results. Epilepsia. 1990;31 Suppl 2:S40-3. doi: 10.1111/j.1528-1157.1990.tb05848.x.
PubMed 2121469Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.
PubMed 25614179Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part II. Headache. 2016 Feb;56(2):259-66. doi: 10.1111/head.12650. Epub 2015 Sep 18.
PubMed 26381725Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R. Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. J Headache Pain. 2015;16:543. doi: 10.1186/s10194-015-0543-3. Epub 2015 Jul 9.
PubMed 26156114Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, Simmons KA, Mullin C, Liebler EJ, Goadsby PJ, Saper JR; EVENT Study Group. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Neurology. 2016 Aug 2;87(5):529-38. doi: 10.1212/WNL.0000000000002918. Epub 2016 Jul 13.
PubMed 27412146Tassorelli C, Grazzi L, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Dorlas S, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P; PRESTO Study Group. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018 Jul 24;91(4):e364-e373. doi: 10.1212/WNL.0000000000005857. Epub 2018 Jun 15.
PubMed 29907608Beh SC, Friedman DI. Acute vestibular migraine treatment with noninvasive vagus nerve stimulation. Neurology. 2019 Oct 29;93(18):e1715-e1719. doi: 10.1212/WNL.0000000000008388. Epub 2019 Sep 25.
PubMed 31554650Busch V, Zeman F, Heckel A, Menne F, Ellrich J, Eichhammer P. The effect of transcutaneous vagus nerve stimulation on pain perception--an experimental study. Brain Stimul. 2013 Mar;6(2):202-9. doi: 10.1016/j.brs.2012.04.006. Epub 2012 May 7.
PubMed 22621941Moller M, Mehnert J, Schroeder CF, May A. Noninvasive vagus nerve stimulation and the trigeminal autonomic reflex: An fMRI study. Neurology. 2020 Mar 10;94(10):e1085-e1093. doi: 10.1212/WNL.0000000000008865. Epub 2020 Feb 6.
PubMed 32029547
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters In Healthy Young Individuals: Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT04768738
- Acronym / sponsor ID
- VNS001 / VNS001
- Conditions
- Healthy, Activity, Motor
- Keywords
- Transcutaneous auricular Vagus Nerve Stimulation, Sportive Performance, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 24 Feb 2021 (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.
OBJECTIVE: The aim of this study is to investigate the effect of non-invasive auricular VNS (Vagus Nerve Stimulation) on sportive performance and physiological parameters in healthy individuals.
MATERIAL AND METHOD: 46 healthy young individuals aged 19.2(±1.5) years participated in the study. The participants were randomly divided into 3 groups as Above Threshold Group (n:15; 10 females, 5 males), Under Threshold Group (n:15; 10 females, 5 males) and Control Group (no stimulation) (n:16; 11 females, 5 males) according to the sensation of electrical current on ears. The participants were evaluated 3 times; before the application, after the first and second bicycle exercises. Numerical pain scale (NPS), pulse rate, blood pressure, respiratory rate, and distance travelled during exercise for sportive performance were recorded in kilometers as the evaluation method. The stimulation was done during the first bicycle exercise with 5 minutes of duration. The Kruskal-wallis, mann-whitney u test were used for the quantitative independent data obtained. In the analysis of qualitative independent data, chi-squared test was used.
Detailed description
This study included 46 individuals aged 18-35 years in the home patient care laboratory at Sinop University Vocational School of Turkeli. Priorities were explained and the permission of the individuals was obtained. The number of females and males was divided into 3 groups as randomized. Participants were evaluated by Numerical pain scale (NPS), pulse rate, blood pressure, respiratory rate, and saturation measurement. In addition, the distance travelled during the exercise for sportive performance was recorded in kilometers. In the study, evaluation was conducted 3 times before the application, after the first and second bicycle exercises.
The study was double-blind randomized. Participants in the whole group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes. In all groups Vagustim device was used for stimulation. In the above threshold group, biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes. VNS was applied bilaterally to transmit current from the tragus and concha parts of the ear. After the first bicycle exercise, the participants were re-evaluated. In the second bicycle exercise, it was asked to perform for 5 minutes under the same load without any application. The study was evaluated for the third time and the study was completed.
In the subthreshold group, the parameters were the same but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes. It was re-evaluated after the first bicycle exercise. In the second bicycle exercise, he was asked to perform bicycle exercise with maximum performance for 5 minutes under the same load without any application. The study was evaluated for the third time and the study was completed.
In the control group, bicycle exercise was performed under the same load with the current-free headset produced for sham applications for 5 minutes. Participants were shown that the device was working, but no current was given. It was re-evaluated after the first bicycle exercise. In the second bicycle exercise, the device was removed and asked to perform bicycle exercise with maximum performance for 5 minutes under the same load. The study was evaluated for the third time and the study was completed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 46 healthy young individuals aged 19.2±1.5 years participated in the study. The participants were randomly divided into 3 groups as Above Threshold Group (n:15; 10 females, 5 males), Under Threshold Group (n:15; 10 females, 5 males) and Control Group (no stimulation) (n:16; 11 females, 5 males) according to the sensation of electrical current on ears. The participants were evaluated 3 times; before the application, after the first and second bicycle exercises. Numerical pain scale (NPS), pulse rate, blood pressure, respiratory rate, and distance travelled during exercise for sportive performance were recorded in kilometers as the evaluation method. The stimulation was done during the first bicycle exercise with 5 minutes of duration. The Kruskal-wallis, mann-whitney u test were used for the quantitative independent data obtained. In the analysis of qualitative independent data, chi-squared test was used.
| Arm | Type | Receives |
|---|---|---|
| Above Threshold Group | Experimental | Device: Auricular Vagus Nerve Stimulation Level Of Above Threshold, Diagnostic Test: 5 Minutes Bicycle ExerciseIn the above threshold group, biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes. |
| Subthreshold Group | Experimental | Device: Auricular Vagus Nerve Stimulation Level Of Subthreshold, Diagnostic Test: 5 Minutes Bicycle ExerciseIn the subthreshold group, biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The parameters were the same with Above Threshold Group but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes. |
| Control Group | Sham comparator | Device: Auricular Vagus Nerve Stimulation Sham Method, Diagnostic Test: 5 Minutes Bicycle ExerciseIn the control group, bicycle exercise was performed under the same load with the current-free headset produced for sham applications for 5 minutes. Participants were shown that the device was working, but no current was given. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-35 years age
- Being healthy
Key exclusion criteria (2 listed)
- any known disease
- any drug usage
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 Stimulation Level Of Above ThresholdBiphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes. | Device | Above Threshold Group |
| Auricular Vagus Nerve Stimulation Level Of SubthresholdAlso: Level Of Subthresholdbiphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The parameters were the same with Above Threshold Group but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes. | Device | Subthreshold Group |
| Auricular Vagus Nerve Stimulation Sham MethodAlso: Sham MethodParticipants were shown that the device was working, but no current was given. | Device | Control Group |
| 5 Minutes Bicycle ExerciseAlso: Bicycle ExerciseParticipants in this group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes. | Diagnostic test | Above Threshold Group, Control Group, Subthreshold Group |
Primary outcome
Sportive performance
Time frame: Change from Baseline at Second Exercise
Athletic performance during exercise in healthy individuals, cycling length in kilometers. Measured twice, during first and second exercises.
11 secondary outcomes
Pulse
Time frame: Change from Baseline at 5 minutes
Pulse
Time frame: 15 minutes
Numerical pain scale (NPS),
Time frame: Change from Baseline at 15 minutes
Respiratory Rate
Time frame: Change from Baseline at 5 minutes
Respiratory Rate
Time frame: 15 minutes
Systolic Blood Pressure
Time frame: Change from Baseline at 5 minutes
Systolic Blood Pressure
Time frame: 15 minutes
Diastolic Blood Pressure
Time frame: Change from Baseline at 5 minutes
Diastolic Blood Pressure
Time frame: 15 minutes
Saturation
Time frame: Change from Baseline at 5 minutes
Saturation
Time frame: 15 minutes
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 24 Feb 2021.
- BackgroundNur Gökçe, E , Pınar Cengi̇z, Z , Erbaş, O . (2018). Uzun ömrün sırrı: Vagus siniri . İstanbul Bilim Üniversitesi Florence Nightingale Tıp Dergisi , 4 (3) , 154-165 . Retrieved from https://dergipark.org.tr/tr/pub/ibufntd/issue/39718/470405
- BackgroundTracey, K.J., Inhibition of inflammatory cytokine production by cholinergic agonists and vagus nerve stimulation. 2003, Google Patents
- Background: PubMed 30406957Hong GS, Zillekens A, Schneiker B, Pantelis D, de Jonge WJ, Schaefer N, Kalff JC, Wehner S. Non-invasive transcutaneous auricular vagus nerve stimulation prevents postoperative ileus and endotoxemia in mice. Neurogastroenterol Motil. 2019 Mar;31(3):e13501. doi: 10.1111/nmo.13501. Epub 2018 Nov 8.
- Background: PubMed 26596640Liu JJ, Huang N, Lu Y, Zhao M, Yu XJ, Yang Y, Yang YH, Zang WJ. Improving vagal activity ameliorates cardiac fibrosis induced by angiotensin II: in vivo and in vitro. Sci Rep. 2015 Nov 24;5:17108. doi: 10.1038/srep17108.
- Background: PubMed 23948774Lataro RM, Silva CA, Fazan R Jr, Rossi MA, Prado CM, Godinho RO, Salgado HC. Increase in parasympathetic tone by pyridostigmine prevents ventricular dysfunction during the onset of heart failure. Am J Physiol Regul Integr Comp Physiol. 2013 Oct 15;305(8):R908-16. doi: 10.1152/ajpregu.00102.2013. Epub 2013 Aug 15.
- Background: PubMed 28065837Dalli J, Colas RA, Arnardottir H, Serhan CN. Vagal Regulation of Group 3 Innate Lymphoid Cells and the Immunoresolvent PCTR1 Controls Infection Resolution. Immunity. 2017 Jan 17;46(1):92-105. doi: 10.1016/j.immuni.2016.12.009. Epub 2017 Jan 5.
- Background: PubMed 2121469Penry JK, Dean JC. Prevention of intractable partial seizures by intermittent vagal stimulation in humans: preliminary results. Epilepsia. 1990;31 Suppl 2:S40-3. doi: 10.1111/j.1528-1157.1990.tb05848.x.
- Background: PubMed 25614179Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.
- Background: PubMed 26381725Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part II. Headache. 2016 Feb;56(2):259-66. doi: 10.1111/head.12650. Epub 2015 Sep 18.
- Background: PubMed 26156114Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R. Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. J Headache Pain. 2015;16:543. doi: 10.1186/s10194-015-0543-3. Epub 2015 Jul 9.
- Background: PubMed 27412146Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, Simmons KA, Mullin C, Liebler EJ, Goadsby PJ, Saper JR; EVENT Study Group. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Neurology. 2016 Aug 2;87(5):529-38. doi: 10.1212/WNL.0000000000002918. Epub 2016 Jul 13.
- Background: PubMed 29907608Tassorelli C, Grazzi L, de Tommaso M, Pierangeli G, Martelletti P, Rainero I, Dorlas S, Geppetti P, Ambrosini A, Sarchielli P, Liebler E, Barbanti P; PRESTO Study Group. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study. Neurology. 2018 Jul 24;91(4):e364-e373. doi: 10.1212/WNL.0000000000005857. Epub 2018 Jun 15.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Level Of Above Threshold, Auricular Vagus Nerve Stimulation Level Of Subthreshold and 5 Minutes Bicycle Exercise in people with Healthy and Activity, Motor, run by Sinop 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 2 inclusion and 2 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 24 Feb 2021. 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?
Sportive performance (time frame: Change from Baseline at Second Exercise). 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 NCT04768738, which also lists 28 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 24 Feb 2021.