Efficacy, SelfNANSANCT06281795
Neuromodulation of the Autonomic Nervous System in Athletes
A study testing tVNS in people with Efficacy, Self and Fatigue; Muscle, Heart, run by Bakulev Scientific Center of Cardiovascular Surgery at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Efficacy, Self, Fatigue; Muscle, Heart, Fatigue, Mental
- What is being tested?
- tVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
Krasnodar
About this study
Official title: 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.
Read the 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.
- Being tested
- tVNS
- 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
- Medical subject headings
- Fatigue, Mental Fatigue, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVNSDevice
tVNS will be performed daily after workouts for 60 minutes over a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics of maximum oxygen consumption (VO2max).
During a cardiorespiratory exercise test, the level of VO2max (ml/min/kg) is assessed.
Measured: 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.
Measured: 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.
During the cardiorespiratory exercise test, the treadmill speed (km/h) is estimated at the level of the aerobic metabolic threshold.
Measured: 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.
During the cardiorespiratory exercise test, the HR is estimated at the level of the anaerobic metabolic threshold.
Measured: 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.
During the cardiorespiratory exercise test, the HR is estimated at the level of the aerobic metabolic threshold.
Measured: 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.
During the time analysis of heart rate variability, the RMSSD parameter is estimated.
Measured: 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
During the spectral analysis of heart rate variability, the HF (high frequency) parameter is estimated.
Measured: 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.
The LF/HF ratio is estimated during the spectral analysis of heart rate variability.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Apr 2024
- Primary completion1 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy, SelfStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization of active stimulation vs. sham stimulation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakulev Scientific Center of Cardiovascular Surgery
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Vladimir A Shvartz, MD, Bakulev Scientific Center of Cardiovascular Surgery
- Investigators
- Vasiliy Danilov, Study chair, Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281795
- Sponsor's protocol ID
- 1.24.
- Acronym
- NANSA
- Status last verified
- Jul 2026
- First submitted
- 19 Feb 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of the Autonomic Nervous System in Athletes (NANSA Trial)
- ClinicalTrials.gov ID
- NCT06281795
- Acronym / sponsor ID
- NANSA / 1.24.
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Bakulev Scientific Center of Cardiovascular SurgeryOther government
- 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
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 1:1 randomization of active stimulation vs. sham stimulation
| Arm | Type | Receives |
|---|---|---|
| Active tVNS | Active comparator | Device: tVNSActive 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. |
| Sham tVNS | Sham comparator | Device: tVNSFictitious 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. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tVNStVNS will be performed daily after workouts for 60 minutes over a period of 8 weeks. | Device | Active tVNS, Sham tVNS |
Primary outcome
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 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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- The effect of transcutaneous auricular vagus nerve stimulation on cycling ergometry and recovery in healthy young individualsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasiliy Danilov study chair
Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVNS in people with Efficacy, Self and Fatigue; Muscle, Heart, run by Bakulev Scientific Center of Cardiovascular Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.