Health PeopleNCT06796101
The Effect of Auricular Vagus Nerve Stimulation and Controlled Breathing Exercises on Performance and Autonomic Nervous System
A study testing Vagus Nerve Stimulation in people with Health People and Physical Activity, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
There are many studies in the literature on transcutaneous vagus nerve stimulation (VNS) and controlled breathing exercises (CBE), but there are limited studies examining the effects of both interventions on performance and the autonomic nervous system. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health People, Physical Activity, Autonomic Nerveus System
- What is being tested?
- Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2025to 5 Dec 2025
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals with a moderate level of physical activity according to the International Physical Activity Scale
- No orthopedic obstacle to exertion
- Being male
Who cannot join
- Having any active or chronic disease
- Having cooperation problems
- Using regular medication for any chronic condition within the last year
- Being a smoker
- Having had heart surgery
- Having had surgery on the respiratory system
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahçesehir University
Istanbul, Istanbul, 34353
About this study
Official title: The Effect of Auricular Vagus Nerve Stimulation and Controlled Breathing Exercises on Performance and Autonomic Nervous System in Healthy Individuals
There are many studies in the literature on transcutaneous vagus nerve stimulation (VNS) and controlled breathing exercises (CBE), but there are limited studies examining the effects of both interventions on performance and the autonomic nervous system.
The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.
Read the detailed description
The sympathetic and parasympathetic divisions of the autonomic nervous system affect the function of many organs, glands, and involuntary muscles in the body. The sympathetic and parasympathetic nervous systems often play opposing roles in the body, one is suppressed when the other increases activity. With the beginning of exercise or sports activity, sympathetic activity in the body increases and after a certain period reaches a plateau value at maximum activity. With the end of sports activity, the suppressed parasympathetic activity increases, and the sympathetic system returns to its resting state over time.
Low sympathetic activity and/or high parasympathetic activity and low heart rate before training or exercise can be considered as performance indicators. It also indicates that recovery from the previous training or exercise is adequate. Parasympathetic system activation continues for up to 48 hours after exercise. If the exercise is intense and persistent, parasympathetic system activity can last up to 72 hours. In addition, due to the increase in anaerobic respiratory rate during exercise, there may be decreases in parasympathetic reactivation.
Transcutaneous vagus nerve stimulation (VNS) can affect cardiovascular parameters both at rest and during exercise. VNS improves autonomic modulation and positively reduces pain and fatigue associated with cycling exercise. On the other hand, VNS is particularly useful in reducing pain and fatigue during and after competition.
Slow breathing modulates the activity of the vagus nerve. Controlled breathing exercises (CBE) directly affect the respiratory rate, which can lead to faster physiological and psychological calming effects by increasing vagal tone during slow expiration. CBE increase heart rate variability in healthy participants.
The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.
- Being tested
- Vagus Nerve Stimulation, Controlled breathing exercises
- Keywords
- Transcutaneous vagus nerve stimulation, Performance, Controlled breathing exercises, Autonomic nervous system, recreactional
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve StimulationDevice
In the study, CE certified vagus nerve stimulation device Vagustim will be used. Transcutaneous auricular vagus nerve stimulation will be applied bilaterally. The stimulation pulse width is 300 microseconds, frequency is 10 Hz and will be applied biphasically for 20 minutes.
Controlled breathing exercisesOther
A controlled breathing exercise group will continue for a total of 2 weeks and will receive 10 sessions of 20 minutes per day.
The thoracic expansion exercise will be performed in 10 repetitions. In each intervention session, 2 sets of nadi shodhana pranayama consisting of 8 respiratory cycles will be applied to the patients, with a 2-minute rest period between the sets. Kapalabhati will be practised for 3 minutes, with 15 quick breaths in 10 seconds followed by a 20-second break (a total of 30 breaths per minute). In each session, 2 sets of bhramari pranayama consisting of 10 breathing cycles will be performed at a low respiratory rate, with a 1-minute rest period between sets. The physiological sigh exercise involves the first inspiration phase being 1 second, the second phase 0.25 seconds, and the exhalation 2 seconds for 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneus vagus nerve stimulation | Experimental | This group will receive Transcutaneous vagus nerve stimulation from bilateral ear for two weeks, 10 sessions. Receives: Device: Vagus Nerve Stimulation |
| Controlled breathing exercise group | Experimental | Controlled breathing exercises include thoracic expansion exercises, Nadi Shodhana Pranayama, Bhramari Pranayama, Kapalabhati and Physiological-sighing exercises. Receives: Other: Controlled breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Individuals will be taken to the treadmill and the distance and time taken until the maximum heart rate value reaches 80% will be recorded. The maximum heart rate value will be determined for each individual according to the formula 220-age.
The participants will walk at a speed of 2 km/h for 1 minute, at a speed of 4 km/h for 1 minute and at a speed of 6 km/h, and the distance and time taken until the maximum heart rate reaches 80% will be recorded. In the termination phase of the run, a walk will be performed at a speed of 4 km/h for 1 minute and a speed of 2 km/h for 1 minute and will be completed.
Measured: Baseline and 2 weeks.
Autonomic nervous system
Heart rate change will be evaluated for the evaluation of the autonomic nervous system. Polar H9 heart rate sensor chest strap and wristwatch will be used to measure analytical heart rate change. During the assessment, the participant will be seated in a chair and the Polar system chest strap will be placed just above the sternum, and ultrasound gel will be used to increase the sensor's conductivity. This method is valid with an electrocardiogram. Heart rate variability parameters such as RMSSD, LF, and HF will be measured.
Measured: Baseline and 2 weeks.
Secondary outcomes (6)
International Physical Activity Questionnaire
International Physical Activity Questionnaire is used to determine the activity levels of individuals. IPAQ Short Form, consisting of seven questions, provides information on the time spent walking, moderate-intensity and vigorous-intensity activities, and the time spent sitting. The calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Measured: Baseline
Modified Borg Scale
Developed by Gunnar Borg, this scale includes values from 1 to 10 and difficulty statements written next to some of these values. This scale, used to determine the intensity of exercises and training, is a subjective method in which individuals determine the difficulty level of the exercise and training themselves.
Measured: Baseline and 2 weeks.
Perceived Stress Scale
It is used to determine the stress level of individuals. The scale consists of 10 items in total. The items of the scale are answered using a 5-point Likert scale ranging from 0 (never) to 4 (very often). The total score varies between 0-40. It is concluded that as the score obtained from the scale increases, the perceived stress increases.
Measured: Baseline and 2 weeks.
Blood Pressure Measurement
Blood pressure measurement will be done using an Omron brand digital wrist type blood pressure monitor. Before taking the measurement, individuals will be asked to rest for at least 5 minutes to ensure that they are relaxed for accurate measurement.
Measured: Baseline and 2 weeks.
Pulse
Pulse measurement will be done with a finger-type Pulse oximeter device.
Measured: Baseline and 2 weeks.
Oxygen Saturation
Pulse oximetry is a noninvasive, painless and reliable method used to measure oxygen saturation (SpO2) in arterial blood. Oxygen saturation measurement will be done with a finger-type pulse oximetry device.
Measured: Baseline and 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start9 Jul 2025
- Primary completion21 Nov 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PeopleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals who are moderately physically active according to the physical activity scale between the ages of 18-35 who met the inclusion criteria will be included in the study. The sample size of the study is calculated as 64 and randomized to vagus stimulation and controlled breathing exercise groups. All evaluations of the participants will be held at Bahçeşehir University Faculty of Health Sciences Biomechanics chiropractic laboratory.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Okan Sahin, Bahçeşehir University
- Investigators
- Okan ŞAHİN, PT, MSc, Principal investigator, Bahçeşehir UniversityAli Veysel ÖZDEN, MD, PHD, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796101
- Sponsor's protocol ID
- ODRP-2025
- Status last verified
- Sep 2025
- First submitted
- 16 Jan 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auricular Vagus Nerve Stimulation and Controlled Breathing Exercises on Performance and Autonomic Nervous System in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06796101
- Acronym / sponsor ID
- ODRP-2025
- Keywords
- Transcutaneous vagus nerve stimulation, Performance, Controlled breathing exercises, Autonomic nervous system, recreactional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 28 Jan 2025 (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 many studies in the literature on transcutaneous vagus nerve stimulation (VNS) and controlled breathing exercises (CBE), but there are limited studies examining the effects of both interventions on performance and the autonomic nervous system.
The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.
Detailed description
The sympathetic and parasympathetic divisions of the autonomic nervous system affect the function of many organs, glands, and involuntary muscles in the body. The sympathetic and parasympathetic nervous systems often play opposing roles in the body, one is suppressed when the other increases activity. With the beginning of exercise or sports activity, sympathetic activity in the body increases and after a certain period reaches a plateau value at maximum activity. With the end of sports activity, the suppressed parasympathetic activity increases, and the sympathetic system returns to its resting state over time.
Low sympathetic activity and/or high parasympathetic activity and low heart rate before training or exercise can be considered as performance indicators. It also indicates that recovery from the previous training or exercise is adequate. Parasympathetic system activation continues for up to 48 hours after exercise. If the exercise is intense and persistent, parasympathetic system activity can last up to 72 hours. In addition, due to the increase in anaerobic respiratory rate during exercise, there may be decreases in parasympathetic reactivation.
Transcutaneous vagus nerve stimulation (VNS) can affect cardiovascular parameters both at rest and during exercise. VNS improves autonomic modulation and positively reduces pain and fatigue associated with cycling exercise. On the other hand, VNS is particularly useful in reducing pain and fatigue during and after competition.
Slow breathing modulates the activity of the vagus nerve. Controlled breathing exercises (CBE) directly affect the respiratory rate, which can lead to faster physiological and psychological calming effects by increasing vagal tone during slow expiration. CBE increase heart rate variability in healthy participants.
The investigators aim to contribute to the literature by examining the effects of VNS and CBE on performance and the autonomic nervous system in moderately physically active individuals and their superiority over each other.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individuals who are moderately physically active according to the physical activity scale between the ages of 18-35 who met the inclusion criteria will be included in the study. The sample size of the study is calculated as 64 and randomized to vagus stimulation and controlled breathing exercise groups. All evaluations of the participants will be held at Bahçeşehir University Faculty of Health Sciences Biomechanics chiropractic laboratory.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneus vagus nerve stimulation | Experimental | Device: Vagus Nerve StimulationThis group will receive Transcutaneous vagus nerve stimulation from bilateral ear for two weeks, 10 sessions. |
| Controlled breathing exercise group | Experimental | Other: Controlled breathing exercisesControlled breathing exercises include thoracic expansion exercises, Nadi Shodhana Pranayama, Bhramari Pranayama, Kapalabhati and Physiological-sighing exercises. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals with a moderate level of physical activity according to the International Physical Activity Scale
- No orthopedic obstacle to exertion
- Being male
Key exclusion criteria (6 listed)
- Having any active or chronic disease
- Having cooperation problems
- Using regular medication for any chronic condition within the last year
- Being a smoker
- Having had heart surgery
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 |
|---|---|---|
| Vagus Nerve StimulationIn the study, CE certified vagus nerve stimulation device Vagustim will be used. Transcutaneous auricular vagus nerve stimulation will be applied bilaterally. The stimulation pulse width is 300 microseconds, frequency is 10 Hz and will be applied biphasically for 20 minutes. | Device | Transcutaneus vagus nerve stimulation |
| Controlled breathing exercisesA controlled breathing exercise group will continue for a total of 2 weeks and will receive 10 sessions of 20 minutes per day. The thoracic expansion exercise will be performed in 10 repetitions. In each intervention session, 2 sets of nadi shodhana pranayama consisting of 8 respiratory cycles will be applied to the patients, with a 2-minute rest period between the sets. Kapalabhati will be practised for 3 minutes, with 15 quick breaths in 10 seconds followed by a 20-second break (a total of 30 breaths per minute). In each session, 2 sets of bhramari pranayama consisting of 10 breathing cycles will be performed at a low respiratory rate, with a 1-minute rest period between sets. The physiological sigh exercise involves the first inspiration phase being 1 second, the second phase 0.25 seconds, and the exhalation 2 seconds for 3 minutes. | Other | Controlled breathing exercise group |
Primary outcome
Performance
Time frame: Baseline and 2 weeks.
Individuals will be taken to the treadmill and the distance and time taken until the maximum heart rate value reaches 80% will be recorded. The maximum heart rate value will be determined for each individual according to the formula 220-age. The participants will walk at a speed of 2 km/h for 1 minute, at a speed of 4 km/h for 1 minute and at a speed of 6 km/h, and the distance and time taken until the maximum heart rate reaches 80% will be recorded. In the termination phase of the run, a walk will be performed at a speed of 4 km/h for 1 minute and a speed of 2 km/h for 1 minute and will be completed.
Autonomic nervous system
Time frame: Baseline and 2 weeks.
Heart rate change will be evaluated for the evaluation of the autonomic nervous system. Polar H9 heart rate sensor chest strap and wristwatch will be used to measure analytical heart rate change. During the assessment, the participant will be seated in a chair and the Polar system chest strap will be placed just above the sternum, and ultrasound gel will be used to increase the sensor's conductivity. This method is valid with an electrocardiogram. Heart rate variability parameters such as RMSSD, LF, and HF will be measured.
6 secondary outcomes
International Physical Activity Questionnaire
Time frame: Baseline
Modified Borg Scale
Time frame: Baseline and 2 weeks.
Perceived Stress Scale
Time frame: Baseline and 2 weeks.
Blood Pressure Measurement
Time frame: Baseline and 2 weeks.
Pulse
Time frame: Baseline and 2 weeks.
Oxygen Saturation
Time frame: Baseline and 2 weeks.
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 9 Dec 2025.
- 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.
Okan ŞAHİN, PT, MSc principal investigator
Bahçeşehir University
Ali Veysel ÖZDEN, MD, PHD study director
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulation in people with Health People and Physical Activity, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 9 Dec 2025. 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 Turkey (Türkiye). 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. 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?
Performance (time frame: Baseline and 2 weeks.). 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 9 Dec 2025.