NCT05778058

The Effect of Vagus Nerve Stimulation on Cycling Ergometry and Recovery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sinop University · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy
• Sports Physical Therapy
• Activity, Motor

Interventions

Type	Name	Description
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.
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.
DEVICE	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.
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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-06-01
• Completion: 2022-08-01
• First posted: 2023-03-21
• Last updated: 2023-03-21

Locations

1 site across 1 country: Turkey (Türkiye)