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Trial record 4 of 8 for:    the effect of auricular nerve stimulation

The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters (VNS001)

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ClinicalTrials.gov Identifier: NCT04768738
Recruitment Status : Completed
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
SEFA HAKTAN HATIK, Sinop University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Healthy Activity, Motor Device: Auricular Vagus Nerve Stimulation Level Of Above Threshold Device: Auricular Vagus Nerve Stimulation Level Of Subthreshold Device: Auricular Vagus Nerve Stimulation Sham Method Diagnostic Test: 5 Minutes Bicycle Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect Of Transcutaneous Auricular Vagus Nerve Stimulation On Sports Performance And Physiological Parameters In Healthy Young Individuals: Randomized, Double-Blind Study
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Above Threshold Group
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.
Device: Auricular Vagus Nerve Stimulation Level Of Above Threshold
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.

Diagnostic Test: 5 Minutes Bicycle Exercise
Participants in this group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes.
Other Name: Bicycle Exercise

Experimental: Subthreshold Group
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.
Device: Auricular Vagus Nerve Stimulation 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.
Other Name: Level Of Subthreshold

Diagnostic Test: 5 Minutes Bicycle Exercise
Participants in this group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes.
Other Name: Bicycle Exercise

Sham Comparator: Control Group
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.
Device: Auricular Vagus Nerve Stimulation Sham Method
Participants were shown that the device was working, but no current was given.
Other Name: Sham Method

Diagnostic Test: 5 Minutes Bicycle Exercise
Participants in this group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes.
Other Name: Bicycle Exercise




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pulse [ Time Frame: Change from Baseline at 5 minutes ]
    Heart beats per minute. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.

  2. Pulse [ Time Frame: 15 minutes ]
    Heart beats per minute. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.

  3. Numerical pain scale (NPS), [ Time Frame: Change from Baseline at 15 minutes ]
    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.

  4. Respiratory Rate [ Time Frame: Change from Baseline at 5 minutes ]
    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.

  5. Respiratory Rate [ Time Frame: 15 minutes ]
    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.

  6. Systolic Blood Pressure [ Time Frame: Change from Baseline at 5 minutes ]
    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.

  7. Systolic Blood Pressure [ Time Frame: 15 minutes ]
    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.

  8. Diastolic Blood Pressure [ Time Frame: Change from Baseline at 5 minutes ]
    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.

  9. Diastolic Blood Pressure [ Time Frame: 15 minutes ]
    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.

  10. Saturation [ Time Frame: Change from Baseline at 5 minutes ]
    Percentage of Oxygen saturation in blood. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.

  11. Saturation [ Time Frame: 15 minutes ]
    Percentage of Oxygen saturation in blood. Measured 3 times; before the first exercise, after the first exercise, after the second exercise.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-35 years age
  • Being healthy

Exclusion Criteria:

  • any known disease
  • any drug usage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768738


Locations
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Turkey
Sefa Haktan Hatık
Sinop, Turkeli, Turkey, 57900
Sponsors and Collaborators
Sinop University
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
Sabino-Carvalho, J.L., et al., Non-invasive Vagus Nerve Stimulation Acutely Improves Blood Pressure Control in a Placebo Controlled Study. The FASEB Journal, 2017. 31(1_supplement): p. 848.8-848.8.

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Responsible Party: SEFA HAKTAN HATIK, PT, MSc, PhD(c), Sinop University
ClinicalTrials.gov Identifier: NCT04768738    
Other Study ID Numbers: VNS001
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SEFA HAKTAN HATIK, Sinop University:
Transcutaneous auricular Vagus Nerve Stimulation
Sportive Performance
Physiological Parameters