Actively Recruiting
Neuromodulation of the Autonomic Nervous System in Athletes (NANSA Trial)
Led by Bakulev Scientific Center of Cardiovascular Surgery · Updated on 2025-06-26
125
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Bakulev Scientific Center of Cardiovascular Surgery
Lead Sponsor
F
Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of transcutaneous vagus nerve stimulation (tVNS) on athletes to help improve recovery after intense physical exercise. This approach uses low-frequency electrical currents applied to the auricular branch of the vagus nerve, which influences cardiovascular, respiratory, and immune functions. The study aims to assess how this stimulation affects the functional reserve of these systems during the recovery period after high-intensity training sessions. Participants will be randomly assigned to one of two groups: active tVNS or sham (fictitious) tVNS. The active group receives stimulation with an ear clip on the left ear at 20 Hz frequency for 60 minutes daily after workouts over 8 weeks. The sham group receives a similar setup but with a research-mode device that mimics stimulation without therapeutic effect. This design allows comparison of the true effects of tVNS on recovery. Throughout the 8-week study, participants undergo assessments including maximum oxygen consumption (VO2max) and treadmill speed at anaerobic and aerobic metabolism thresholds, measured at the start and end of the study. Heart rate and other heart rate variability parameters will also be monitored. These evaluations help researchers understand how tVNS influences physical and cardiovascular recovery. The total study period spans 8 weeks with daily post-exercise sessions and outcome measurements at baseline and study completion.
CONDITIONS
Brief Title
Neuromodulation of the Autonomic Nervous System in Athletes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Professional athletes aged between 15 and 35 years
- Participation in cyclic sports such as swimming, modern pentathlon, athletics, or triathlon
- Participation in difficult coordination sports like dance sports or rhythmic gymnastics
- Sports category no lower than candidate for master of sports
- Voluntary informed consent to participate
You will not qualify if you...
- Atypical ECG changes unrelated to physical exertion, including T wave inversion, ST-segment depression, pathological Q waves, left atrial enlargement, right ventricular hypertrophy, ventricular pre-excitation, bundle branch block, prolonged or shortened QT interval, or Brugada-like early repolarization
- Heart rhythm and conduction disorders such as frequent ventricular or supraventricular extrasystoles, first-degree AV block (PQ > 0.21 s), or second/third-degree AV block
- Severe sinus bradycardia with resting heart rate below 40 bpm
- Use of glucocorticosteroids within the last month
- Use of any antiarrhythmic drugs, including beta-blockers, within the last month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive daily transcutaneous vagus nerve stimulation (tVNS) after workouts using a device attached to the ear for 60 minutes.
Daily stimulation sessions after workouts for 8 weeks
Trial Site Locations
Total: 1 location
1
Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
Krasnodar, Russia
Actively Recruiting
Research Team
V
Vladimir Shvartz
V
Vasiliy Danilov
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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