NCT06281795 Neuromodulation of the Autonomic Nervous System in Athletes
| NCT ID | NCT06281795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bakulev Scientific Center of Cardiovascular Surgery |
| Condition | Efficacy, Self |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2024-04-01 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Vasiliy Danilov
STUDY CHAIR
Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
Frequently Asked Questions
Who can join the NCT06281795 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 35 Years, studying Efficacy, Self. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06281795 currently recruiting?
Yes, NCT06281795 is actively recruiting participants. Contact the research team at vashvarts@bakulev.ru for enrollment information.
Where is the NCT06281795 trial being conducted?
This trial is being conducted at Krasnodar, Russia.
Who is sponsoring the NCT06281795 clinical trial?
NCT06281795 is sponsored by Bakulev Scientific Center of Cardiovascular Surgery. The principal investigator is Vasiliy Danilov at Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION. The trial plans to enroll 125 participants.