The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery

Healthy Clinical Trial

— TAVNSCER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05778058
• Other study ID #: VNS003
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2023
• Source: Sinop University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Activity, Motor
• Healthy
• Sports Physical Therapy

Intervention

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.
• 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.
• Bilateral Sham Stimulation
Participants were shown that the device was working, but no current was given.

Diagnostic Test:
• Bicycle Ergometer Test
Participants in this group were asked to perform bicycle exercise with maximum performance under 30 watts for 30 minutes.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Sefa Haktan Hatik	Sinop

Sponsors (1)

Lead Sponsor	Collaborator
Sinop University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of autonomous parameters	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.
Primary	Numerical Fatigue Rating Scale	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.
Primary	Numerical Pain Rating Scale	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.
Primary	Bicycle Ergometer Test	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.
Primary	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.	It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.
Primary	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.	It was measured 4 times in total on the 1st and 2nd days of the 4-day protocol.