Vagus Nerve StimulationsNCT06740032
Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise
A study testing Transcutaneous vagus nerve stimulation and Deep breath exercise in people with Vagus Nerve Stimulations, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults. Are vagal stimulation and breathing exercises effective on autonomic functions and the somatic system in healthy adults? Participants' results for autonomic functions and somatic… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vagus Nerve Stimulations
- What is being tested?
- Transcutaneous vagus nerve stimulation and Deep breath exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2022to 28 Aug 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- could read and write Turkish
Who cannot join
- being 18 years or older having no known acute or chronic disease, and no previous treatment with vagus nerve stimulation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Gelisim University
Istanbul, Avcılar, 34310
About this study
Official title: Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise on the Autonomic Nervous System Activity and Biomechanical Properties of the Muscle in Healthy People
The goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults.
Are vagal stimulation and breathing exercises effective on autonomic functions and the somatic system in healthy adults? Participants' results for autonomic functions and somatic system will be compared for both groups.
- Conditions
- Vagus Nerve Stimulations
- Being tested
- Transcutaneous vagus nerve stimulation, Deep breath exercise
- Keywords
- Auricular vagus nerve stimulation, deep breathing exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve stimulationOther
Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together
Deep breath exerciseOther
Investigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together
| Study group | Role | What they receive |
|---|---|---|
| autonomic function | Active comparator | Not described Receives: Other: Transcutaneous vagus nerve stimulation; Other: Deep breath exercise |
| somatic function | Active comparator | Not described Receives: Other: Transcutaneous vagus nerve stimulation; Other: Deep breath exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRV results
Measuring autonomic values for 5 minutes
Measured: 5 minutes
Muscle Natural Oscillation Frequency
Biomechanical measurements of specific muscles
Measured: 5 minutes
Muscle Dynamic Stiffness [N/m]
measured using the myoton device
Measured: 5 minutes
Mechanical Stress Relaxation Time [ms]
measured using the myoton device
Measured: 5 minutes
Secondary outcomes (3)
Perceived stress scale
Evaluation of stress levels with the specified questionnaire
Measured: 5 minutes
Pulse rate
Measuring with a sphygmomanometer
Measured: 5 minutes
blood pressure
Measuring blood pressure with a sphygmomanometer
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start27 Feb 2022
- Primary completion12 Jun 2022
- Study completion28 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vagus Nerve StimulationsStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740032
- Sponsor's protocol ID
- VNS06.01.2022/01
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 18 Dec 2024
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise on the Autonomic Nervous System Activity and Biomechanical Properties of the Muscle in Healthy People
- ClinicalTrials.gov ID
- NCT06740032
- Acronym / sponsor ID
- VNS06.01.2022/01
- Conditions
- Vagus Nerve Stimulations
- Keywords
- Auricular vagus nerve stimulation, deep breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 18 Dec 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.
The goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults.
Are vagal stimulation and breathing exercises effective on autonomic functions and the somatic system in healthy adults? Participants' results for autonomic functions and somatic system will be compared for both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autonomic function | Active comparator | Other: Transcutaneous vagus nerve stimulation, Other: Deep breath exercise |
| somatic function | Active comparator | Other: Transcutaneous vagus nerve stimulation, Other: Deep breath exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- could read and write Turkish
Key exclusion criteria (1 listed)
- being 18 years or older having no known acute or chronic disease, and no previous treatment with vagus nerve stimulation
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 |
|---|---|---|
| Transcutaneous vagus nerve stimulationInvestigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together | Other | autonomic function, somatic function |
| Deep breath exerciseInvestigation of the effects of vagus nerve stimulation on the autonomic and somatic systems together | Other | autonomic function, somatic function |
Primary outcome
HRV results
Time frame: 5 minutes
Measuring autonomic values for 5 minutes
Muscle Natural Oscillation Frequency
Time frame: 5 minutes
Biomechanical measurements of specific muscles
Muscle Dynamic Stiffness [N/m]
Time frame: 5 minutes
measured using the myoton device
Mechanical Stress Relaxation Time [ms]
Time frame: 5 minutes
measured using the myoton device
3 secondary outcomes
Perceived stress scale
Time frame: 5 minutes
Pulse rate
Time frame: 5 minutes
blood pressure
Time frame: 5 minutes
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 18 Dec 2024.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagus nerve stimulation and Deep breath exercise in people with Vagus Nerve Stimulations, run by Istanbul Gelisim 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 1 inclusion and 1 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 18 Dec 2024. 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?
HRV results (time frame: 5 minutes). The study lists 4 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 18 Dec 2024.