Sympathetic; ImbalanceNCT07000175
Comparison of Heart Rate Variability Measurement on the Arm and Chest in Vagus Nerve Stimulation
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Sympathetic; Imbalance, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Healthy participants will be included in this study by invitation and randomised into three groups. Participants in each group will receive bilateral transcutaneous vagus nerve stimulation with the same frequency, current transit time and current intensity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sympathetic; Imbalance
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- To know how to read and write Turkish
- Not having any acute or chronic disease
Who cannot join
- Previous application of any neuromodulation method
- Smoking or alcohol use
- Use of any supplementary medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Avrasya University Physical Therapy Laboratory
Trabzon, Ortahisar, 61080
Yavuz Ozoran, Prof.Dr., yavuz.ozoran@avrasya.edu.tr
Ezgi Albayrak, ezgii.karas@gmail.com
About this study
Official title: Comparison of Heart Rate Variability Measurement on the Arm and Chest in Transcutaneous Auricular Vagus Nerve Stimulation
Healthy participants will be included in this study by invitation and randomised into three groups. Participants in each group will receive bilateral transcutaneous vagus nerve stimulation with the same frequency, current transit time and current intensity. Heart rate variability will be measured over the chest in the first group, over the right arm in the second group and over the left arm in the third group. Then, the differences between the groups in heart rate variability parameters (time-dependent, frequency-dependent) will be compared. The aim of this study is to examine the differences between heart rate variability measurements measured at different sites.
Read the detailed description
Heart rate variability is defined as the change in beat-to-beat interval, and the sympathetic and parasympathetic nervous system influences the change in beat-to-beat interval through cardiovascular connections. Heart rate variability measurement can be obtained by different methods. However, which method is more effective is controversial. The aim of this study was to investigate the differences between heart rate variability parameters measured on the chest, right arm and left arm.
Healthy participants aged 18-45 years will be included in the study. The inclusion criteria will be determined as being 18 years of age or older and not having any acute or chronic disease. Exclusion criteria will be determined as being previously involved in any neuromodulation intervention, smoking or alcohol use, and regular medication use.
Participants included in the study will be randomised into three groups and transcutaneous vagus nerve stimulation will be applied. The duration of treatment will be 20 minutes and single session stimulation will be performed. Current intensity, current passage time and frequency will be planned to be the same in each patient. Before and after stimulation, heart rate variability will be measured over the chest in the first group, over the right arm in the second group and over the left arm in the third group. Then, heart rate variability parameters (time-dependent, frequency-dependent) will be compared between the groups.
- Conditions
- Sympathetic; Imbalance
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation
- Keywords
- Heart Rates, Vagus Nerves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Non-invasive transcutaneous vagus nerve stimulation with special earphones placed in the ear will be applied to the participants for 20 minutes and a single session.
| Study group | Role | What they receive |
|---|---|---|
| Measurement over the chest | Active comparator | Heart rate variability will be measured on the chest for 5 minutes before and after transcutaneous vagus nerve stimulation. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Measurement over the right arm | Active comparator | Heart rate variability will be measured on the right arm for 5 minutes before and after transcutaneous vagus nerve stimulation. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Measurement over the left arm | Active comparator | Heart rate variability will be measured on the left arm for 5 minutes before and after transcutaneous vagus nerve stimulation. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Heart rate variability will be measured with a 5-minute short measurement method over the chest, right arm and left arm.
Measured: Baseline and after 20 minutes of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start30 May 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sympathetic; ImbalanceStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A modelling will be created in which the same intervention will be applied to the three groups but the evaluations will be made differently.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Percin, Bahçeşehir University
- Investigators
- Ramazan Cihad Yılmaz, Ph.D., Study director, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000175
- Sponsor's protocol ID
- AVU10002
- Status last verified
- Jul 2025
- First submitted
- 23 May 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gillinov S, Etiwy M, Wang R, Blackburn G, Phelan D, Gillinov AM, Houghtaling P, Javadikasgari H, Desai MY. Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise. Med Sci Sports Exerc. 2017 Aug;49(8):1697-1703. doi: 10.1249/MSS.0000000000001284.
PubMed 28709155
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Heart Rate Variability Measurement on the Arm and Chest in Transcutaneous Auricular Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT07000175
- Acronym / sponsor ID
- AVU10002
- Conditions
- Sympathetic; Imbalance
- Keywords
- Heart Rates, Vagus Nerves
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 2 Jun 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.
Healthy participants will be included in this study by invitation and randomised into three groups. Participants in each group will receive bilateral transcutaneous vagus nerve stimulation with the same frequency, current transit time and current intensity. Heart rate variability will be measured over the chest in the first group, over the right arm in the second group and over the left arm in the third group. Then, the differences between the groups in heart rate variability parameters (time-dependent, frequency-dependent) will be compared. The aim of this study is to examine the differences between heart rate variability measurements measured at different sites.
Detailed description
Heart rate variability is defined as the change in beat-to-beat interval, and the sympathetic and parasympathetic nervous system influences the change in beat-to-beat interval through cardiovascular connections. Heart rate variability measurement can be obtained by different methods. However, which method is more effective is controversial. The aim of this study was to investigate the differences between heart rate variability parameters measured on the chest, right arm and left arm.
Healthy participants aged 18-45 years will be included in the study. The inclusion criteria will be determined as being 18 years of age or older and not having any acute or chronic disease. Exclusion criteria will be determined as being previously involved in any neuromodulation intervention, smoking or alcohol use, and regular medication use.
Participants included in the study will be randomised into three groups and transcutaneous vagus nerve stimulation will be applied. The duration of treatment will be 20 minutes and single session stimulation will be performed. Current intensity, current passage time and frequency will be planned to be the same in each patient. Before and after stimulation, heart rate variability will be measured over the chest in the first group, over the right arm in the second group and over the left arm in the third group. Then, heart rate variability parameters (time-dependent, frequency-dependent) will be compared between the groups.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A modelling will be created in which the same intervention will be applied to the three groups but the evaluations will be made differently.
| Arm | Type | Receives |
|---|---|---|
| Measurement over the chest | Active comparator | Device: Transcutaneous Auricular Vagus Nerve StimulationHeart rate variability will be measured on the chest for 5 minutes before and after transcutaneous vagus nerve stimulation. |
| Measurement over the right arm | Active comparator | Device: Transcutaneous Auricular Vagus Nerve StimulationHeart rate variability will be measured on the right arm for 5 minutes before and after transcutaneous vagus nerve stimulation. |
| Measurement over the left arm | Active comparator | Device: Transcutaneous Auricular Vagus Nerve StimulationHeart rate variability will be measured on the left arm for 5 minutes before and after transcutaneous vagus nerve stimulation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- To know how to read and write Turkish
- Not having any acute or chronic disease
Key exclusion criteria (3 listed)
- Previous application of any neuromodulation method
- Smoking or alcohol use
- Use of any supplementary medication
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 Auricular Vagus Nerve StimulationNon-invasive transcutaneous vagus nerve stimulation with special earphones placed in the ear will be applied to the participants for 20 minutes and a single session. | Device | Measurement over the chest, Measurement over the left arm, Measurement over the right arm |
Primary outcome
Heart Rate Variability
Time frame: Baseline and after 20 minutes of treatment
Heart rate variability will be measured with a 5-minute short measurement method over the chest, right arm and left arm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 28709155Gillinov S, Etiwy M, Wang R, Blackburn G, Phelan D, Gillinov AM, Houghtaling P, Javadikasgari H, Desai MY. Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise. Med Sci Sports Exerc. 2017 Aug;49(8):1697-1703. doi: 10.1249/MSS.0000000000001284.
- Individual participant dataSharing planned: No
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.
Ramazan Cihad Yılmaz, Ph.D. study director
Igdir 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 Transcutaneous Auricular Vagus Nerve Stimulation in people with Sympathetic; Imbalance, 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 3 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: looking for participants now, as of the sponsor's last update on 14 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alper Percin, Ph.D. (+905452557585, alperpercin@avrasya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Baseline and after 20 minutes of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000175, which also lists 1 linked publication.
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 14 Jul 2025.