Clinical trial NCT06281795: Neuromodulation of the Autonomic Nervous System in Athletes
Official title: Neuromodulation of the Autonomic Nervous System in Athletes (NANSA Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Bakulev Scientific Center of Cardiovascular Surgery
Sponsor class: OTHER_GOV
Collaborators: name: Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION
name: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
First posted: 2024-02-28
Enrollment: 125
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization of active stimulation vs. sham stimulation
Primary purpose: TREATMENT

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.

Detailed description: Several studies have shown that transcutaneous vagus nerve stimulation (tVNS) potentially exhibits therapeutic effects similar to its invasive counterpart. tVNS is performed using surface electrodes and low-frequency electrical currents, targeting specific locations, most commonly the auricular branch of the vagus nerve or its cervical branch.

Stimulation of the auricular branch of the vagus nerve activates vagal sensory fibers, simulating sensory input to the brainstem and forming what is known as the auriculo-vagal afferent pathway. Since these fibers project directly to the nucleus of the solitary tract (also known as the solitary tract nucleus), which in turn has direct or indirect projections to nuclei that provide noradrenergic, endorphinergic, and serotonergic fibers in various parts of the brain, regulating systemic parameters of cardiovascular, respiratory, and immune functions, it can be expected that the body's response to stimulation of the auricular branch of the vagus nerve will be systemic.

With the onset of physical exercise, sympathetic activity in the body increases and reaches a plateau value after a certain period of maximum activity. After the end of physical exercise, suppressed parasympathetic activity begins to intensify, and the sympathetic system gradually returns to a resting state. After training, parasympathetic system activation continues for up to 48 hours. In certain types of training, when the frequency of anaerobic respiration increases during physical exertion, a decrease in parasympathetic reactivation may be observed.

In the literature, there are individual studies that have evaluated the effects of transcutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery processes after physical exertion). It has been demonstrated that tVNS in athletes improves heart rate recovery, reduces lactate levels in plasma, reduces pain sensations, decreases overtraining syndrome, and reduces fatigue levels.

The aim of this study is to: evaluate the influence of low-frequency electrical stimulation of the auricular branch of the vagus nerve on the functional reserve of the cardiovascular and respiratory systems in athletes during the post-training period, after high-intensity workouts.

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.

Primary outcomes:
measure: Dynamics of maximum oxygen consumption (VO2max).
timeFrame: 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.
measure: The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism.
timeFrame: 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:
measure: Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism.
timeFrame: 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.
measure: The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism.
timeFrame: 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.
measure: The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism.
timeFrame: 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.
measure: The dynamics of RMSSD.
timeFrame: 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.
measure: HF dynamics
timeFrame: 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.
measure: Dynamics of the LF/HF ratio.
timeFrame: This LF/HF ratio is evaluated at the beginning of the study (initially) and at the end of the study (after 8 weeks) in the active and fictitious stimulation groups.
Other outcomes:
Locations:
city: Krasnodar
country: Russian Federation
facility: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
Study officials:
affiliation: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
name: Vasiliy Danilov
role: STUDY_CHAIR
References: