The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery (TAVNSCER)

March 8, 2023 updated by: Sinop University

he Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Cycling Ergometry and Recovery in Healthy Young Individuals

It is aIt is aimed to examine the possible benefits and effects of the use of Transcutaneous Auricular Vagus Nerve Stimulation to be applied in healthy individuals for sportive purposes on recovery and sportive performance level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The 90 people between the ages of 18-35 will be included in the study. Each participant will be randomly divided into 3 groups to be homogeneous after the necessary calculations are made by evaluating with age, gender, weight, height and body mass index before starting the study.

The groups are; It will be in the form of Unilateral Stimulation (n=30), Bilateral Stimulation (n=30) and Bilateral Sham Stimulation (n=30) groups.

After the initial assessment, participants in all groups will be asked to do 30 minutes of cycling exercise at maximum performance under the same wattage load. Cycling will be re-evaluated after exercise. After the assessment is complete, stimulation will be given with Vagustim for 20 minutes non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.

After the pain and fatigue rating scale, the evaluation will be completed by determining the lactate level in the blood with the Lactat Scout. Vagus nerve stimulation will be applied with the Vagustim device for 20 minutes, keeping it biphasic, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current where the participant feels the current comfortably.

At the end of the Cycling Ergometer Test and Vagus nerve stimulation, the Autonomic Nervous System, pulse and blood pressure will be evaluated with Polar H10 within 5 minutes.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Sinop, Turkey
        • Sefa Haktan Hatik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy individuals between the ages of 18-35,
  • Willingness to participate in the study
  • Having signed the informed consent form

Exclusion Criteria:

  • Cases do not want to continue the study.
  • Having regular sports habits or starting in the working process,
  • Having a disease related to the respiratory system and starting to use drugs
  • Having a disease related to the cardiac system and starting to use drugs
  • Presence of any chronic disease and using a drug related to it

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unilateral Stimulation

After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load.

It will be re-evaluated after the cycling exercise application. After the assessment is complete, stimulation will be given with Vagustim non-invasively for 30 minutes. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.

With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.
Device: Unilateral Stimulation
With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.
Diagnostic test: Bicycle Ergometer Test
Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.
Diagnostic test: Lactat Scout
For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.
Diagnostic test: Polar H10
RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.
Device: Vagustim Device
Vagustim Health Technologies Vagus stimulator device is used for this experiment.
Experimental: Bilateral Stimulation

After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load.

It will be re-evaluated after the cycling exercise application. After the assessment is complete, stimulation will be given with Vagustim non-invasively for 20minutes. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.

With the Vagustim device, vagus nerve stimulation will be applied in bilateral ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.
Diagnostic test: Bicycle Ergometer Test
Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.
Diagnostic test: Lactat Scout
For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.
Diagnostic test: Polar H10
RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.
Device: Vagustim Device
Vagustim Health Technologies Vagus stimulator device is used for this experiment.
Device: Bilateral Stimulation
With the Vagustim device, vagus nerve stimulation will be applied in one ear for 20 minutes, with a frequency of 10 Hz, a pulse width of 300 μs in Modulation mode, and a constant current that the participant will feel the current comfortably.
Sham Comparator: Bilateral Sham Stimulation

After evaluating with 7 different parameters on the first, second, third and fourth days of the protocol, the participants in all groups will be asked to do cycling exercise with maximum performance for 30 minutes under the same wattage load. Bisiklet egzersiz uygulaması sonrasında tekrar değerlendirilecektir.

It will be re-evaluated after the cycling exercise. After the assessment is complete, sham stimulation with Vagustim for 20 minutes will be given non-invasively. After vagus nerve stimulation, a re-evaluation will be made and the protocol for that day will be terminated.
Diagnostic test: Bicycle Ergometer Test
Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.
Diagnostic test: Lactat Scout
For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.
Diagnostic test: Polar H10
RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.
Device: Vagustim Device
Vagustim Health Technologies Vagus stimulator device is used for this experiment.
Device: Bilateral Sham Stimulation
Participants were shown that the device was working, but no current was given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of autonomous parameters
Time Frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.
In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Numerical Fatigue Rating Scale
Time Frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
The fatigue NRS is a patient-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing 'no fatigue' and 10 representing 'as bad as you can imagine'. Patients are asked to 'please rate your fatigue (weariness, tiredness) by selecting the number.
In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Numerical Pain Rating Scale
Time Frame: In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain.
In the 4-day protocol, it was measured 12 times in total, before and after vagus therapy with the bicycle ergometer test.
Bicycle Ergometer Test
Time Frame: It was measured 4 times in aggregation in the 4-day protocol.
All participants will be asked to perform cycling exercise at maximum performance for 30 minutes under a load of 30 watts. Then, the distance (meters) covered during the exercise will be evaluated for the sportive performance of the participants.
It was measured 4 times in aggregation in the 4-day protocol.
Lactat Scout
Time Frame: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
For lactic acid analysis measurement, the middle fingertip of the athlete is disinfected with an alcohol swab and a blood sample is taken by puncturing the finger.The measuring range is 0.5 - 0.25 mmol/L.
It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
Polar H10
Time Frame: It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
RR times transferred to computer with Polar H10 are used in heart rate variability analysis. Heart rate data will be transferred to the Kubios program and heart rate variability parameters will be calculated and data on the autonomic nervous system (RMSSD, PNS index, Stress index, SNS index, pNN50, Power LF, Power HF and LF/HF ratio) will be obtained.
It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinop University

Investigators

  • Study Director: SEFA HAKTAN HATIK, Asst. Prof, Sinop University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VNS003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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