Neuromodulation of the Autonomic Nervous System in Athletes (NANSA)

June 23, 2025 updated by: Vladimir A Shvartz, MD, Bakulev Scientific Center of Cardiovascular Surgery

Neuromodulation of the Autonomic Nervous System in Athletes (NANSA Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Krasnodar, Russian Federation
        • Recruiting
        • Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
        • Contact:
          • Vasiliy Danilov
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active tVNS
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
tVNS will be performed daily after workouts for 60 minutes over a period of 8 weeks.
Sham Comparator: Sham tVNS
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
tVNS will be performed daily after workouts for 60 minutes over a period of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamics of maximum oxygen consumption (VO2max).
Time Frame: 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.
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.
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism.
Time Frame: 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.
During the cardiorespiratory exercise test, the treadmill speed (km/h) is estimated at the level of the aerobic 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.
The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism.
Time Frame: 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.
During the cardiorespiratory exercise test, the HR is estimated at the level of the anaerobic metabolic threshold.
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.
Time Frame: 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.
During the cardiorespiratory exercise test, the HR is estimated at the level of the aerobic metabolic threshold.
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.
Time Frame: 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.
During the time analysis of heart rate variability, the RMSSD parameter is estimated.
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
Time Frame: 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.
During the spectral analysis of heart rate variability, the HF (high frequency) parameter is estimated.
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.
Dynamics of the LF/HF ratio.
Time Frame: 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.
The LF/HF ratio is estimated during the spectral analysis of heart rate variability.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakulev Scientific Center of Cardiovascular Surgery

Collaborators

Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION
Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION

Investigators

  • Study Chair: Vasiliy Danilov, Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.24.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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