Neuromodulation of the Autonomic Nervous System in Athletes

NCT06281795 | Recruiting

• 1 other identifier: 1.24.
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels.

Conditions

Efficacy, Self; Fatigue; Muscle, Heart; Fatigue, Mental; Fatigue; Combat

Keywords

auricular stimulation; auricular vagus nerve stimulation; transcutaneous vagus nerve stimulation (tVNS); vagus nerve stimulation (VNS); heart rate; heart rate variability; power of high-frequency oscillations (HF); power of low-frequency oscillations (LF); LF/HF; index centralization (IC); index of vegetative balance (IVB); athletes; sport; maximum oxygen consumption (VO2max); treadmill speed; anaerobic threshold of metabolism.; aerobic metabolism threshold of metabolism

Outcome Measures

Primary Outcomes (2)

• Dynamics of maximum oxygen consumption (VO2max).

  During a cardiorespiratory exercise test, the level of VO2max (ml/min/kg) is assessed.

  The level of VO2max is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and fictitious stimulation groups.

• The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism.

  During the cardiorespiratory exercise test, the treadmill speed (km/h) is estimated at the level of the anaerobic metabolic threshold.

  Treadmill speed is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.

Secondary Outcomes (6)

• Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism.

  Treadmill speed is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.

• The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism.

  HR is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.

• The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism.

  HR is estimated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and dummy stimulation groups.

• The dynamics of RMSSD.

  This parameter is evaluated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the groups of active and fictitious stimulation.

• HF dynamics

  This parameter is evaluated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the groups of active and fictitious stimulation.

Study Arms (2)

Active tVNS

ACTIVE COMPARATOR

Active stimulation will be carried out using the tVNS device with an ear clip attached to the tragus of the left ear at a frequency of 20 Hz, 200 μs at a current slightly below the discomfort threshold. The device's operating mode is active therapeutic.

Device: tVNS

Sham tVNS

SHAM COMPARATOR

Fictitious stimulation will be carried out using the tVNS device with an ear clip attached to the tragus of the left ear at a frequency of 20 Hz, 200 μs at a current slightly below the discomfort threshold. The device's operating mode is research mode.

Device: tVNS

Interventions

tVNS DEVICE

tVNS will be performed daily after workouts for 60 minutes over a period of 8 weeks.

Active tVNS; Sham tVNS

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Professional athletes over the age of 15 and under the age of 35;
• Cyclic sports (swimming, modern pentathlon, athletics, triathlon);
• Difficult coordination sports (dance sports, rhythmic gymnastics);
• Sports category: no lower than candidate for master of sports;
• Voluntary informed consent.

You may not qualify if:

• Atypical and unrelated to physical exertion changes on the ECG (T wave inversion, st-segment depression, pathological Q waves, signs of left atrial enlargement, signs of right ventricular hypertrophy, ventricular pre-excitation, complete right or left bundle branch block, prolonged or shortened Q-T interval, Brugada-like early repolarization);
• Heart rhythm and conduction disorders (frequent ventricular and supraventricular extrasystoles, first-degree atrioventricular block (P-Q \> 0.21 s, not shortened during hyperventilation or physical exertion), second or third degree);
• Expressed sinus bradycardia with resting heart rate \< 40 bpm;
• Taking glucocorticosteroids in the last 1 month;
• Taking any antiarrhythmic drugs, including beta-blockers.

Sponsors & Collaborators

• Bakulev Scientific Center of Cardiovascular Surgery: lead
• Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION: collaborator
• Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION: collaborator

Study Sites (1)

Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION

Krasnodar, Russia

RECRUITING

Related Links

• The effect of transcutaneous auricular vagus nerve stimulation on cycling ergometry and recovery in healthy young individuals

MeSH Terms

Conditions

Fatigue; Mental Fatigue; Combat Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Vasiliy Danilov

  Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION

  STUDY CHAIR

Central Study Contacts

Vladimir Shvartz

CONTACT

+79032619292; vashvarts@bakulev.ru

Vasiliy Danilov

CONTACT

+79997309494; danilov.vasiliy.37@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DM, Professor

Model Details: 1:1 randomization of active stimulation vs. sham stimulation

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: April 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)