Chronic TinnitusTVNS-TINNNCT07155733
tVNS and Myofascial Release in Tinnitus
A study testing Transcutaneous Vagus Nerve Stimulation, Myofascial Release Exercises and Standard medical treatment in people with Chronic Tinnitus and Subjective Tinnitus, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises in patient wiht chronic subjective tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Tinnitus, Subjective Tinnitus, Neuromodulation
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation, Myofascial Release Exercises and Standard medical treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2025to 10 Oct 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic subjective tinnitus (>6 months)
- Ability to understand and provide written informed consent
- Willingness to comply with study procedures and intervention schedule
- Resistant for medical treatment for subjective tinnitus
- Impacted daily living by tinnitus
Who cannot join
- Diagnoses such as auditory hallucinations, Meniere's disease, vestibular tumor, vertigo, or sudden hearing loss
- Trauma or surgical interventions involving the neck, jaw, or head within the 6 months
- Epilepsy or presence of a cardiac pacemaker (contraindication for tVNS)
- History of acute psychiatric disorders
- Use of ototoxic medications
- Physical limitations that prevent participation in exercise interventions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Meram Faculty of Medicine
Konya, Meram, 42090
About this study
Official title: Comparison Of The Effectiveness Of Myofascial Release Exercises and Vagus Nerve Neuromodulation in Tinnitus Patients: Randomized Controlled Trial
This randomized controlled trial aims to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises in patient wiht chronic subjective tinnitus. Participants will be randomly assigned into three groups: (1) tVNS group, (2) Myofascial exercise group, and (3) Control group receiving standart medical care. The primary outcome is change in tinnitus severity measured by the Tinnitus Handicap Inventory (THI). Secondary outcomes include tinnitus loudness Visual Analouge Scale for Tinnitus (VAS), sleep quality Pitsburgh Sleep Quality Index (PSQI) and audiometric findings.
Read the detailed description
Tinnitus is a common and distressing condition that significantly impairs quality of life. Recent studies suggest that neuromdulation techniques such as vagus nerve stimulation and physical interventions targeting myofascial structures may reduce tinnitus severity. However, evidence remains limited, and comparative effectiveness of these approaches is not well established.
This single-center randomized controlled trial will compare the effects of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises with a control group receiving only medical treatment. A total of 45 participants with chronic subjective tinnitus will be recruited. Participants will be randomized into three groups and receive 10 intervention sessions over three weeks.
The tVNS group will receive transcutaneous stimulation of the auricular branch of the vagus nerve using a TENS (Everyway N604, Taiwan) device. The myofascial group will undergo guided myofascial release targeting cervical muscles in addition to medical treatment. The control group will continue their medical treatment without additional interventions.
The primary outcome measure will be change in tinnitus-related handicap using the Tinnitus Handicap Inventory (THI). Secondary outcomes will include tinnitus loudness assesed by a Visual Analogue Scale for Tinnitus (VAS), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) and audiometric assesments.
The findings from this trial may provide new insights into non-farmacological rehabiliation strategies for tinnitus and clarify the role of neuromodulation compared with physical therapy inreventions.
- Conditions
- Chronic Tinnitus, Subjective Tinnitus, Neuromodulation
- Being tested
- Transcutaneous Vagus Nerve Stimulation, Myofascial Release Exercises, Standard medical treatment
- Keywords
- tinnitus, chronic tinnitus, subjective tinnitus, vagus nerve stimulation, Transcutaneous Vagus Nerve Stimulation (tVNS), Auricular Vagus Nerve Stimulation, Neuromodulation, Myofascial Release, Physical Therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Vagus Nerve StimulationDevice
Participants receive 10 sessions of transcutaneous vagus nerve stimulation over 3 weeks using a TENS device. stimulation is applied to the auricular branch of the vagus nerve (cymba conchae/tragus) for 30 minutes per session. Participants continue usual medical care. Parameters (frequency, pulse width, intencity) are standartized according to safety guidelines. This intervention specifically targets the auricular branch of the vagus nerve, distinguishing it from other device-based intervention such as conventional TENS for pain management or non-auricular vagus stimulation used in other studies.
Myofascial Release ExercisesBehavioural
Participants receive 10 supervised session over 3 weeks focusing on myofascial release of cervical muscles. in addition to their usual medical management for tinnitus. Exercises are designed to reduse muscle tensionpotentially contributing to tinnitus. This intervention is distinct from general physical therapy or standart relaxation exercises beacause it specifically targets myofascial structures implicated in tinnitus pathophysiology.
Standard medical treatmentOther
Participants continue their usual medical management for tinnitus without additional interventions. This group serves as a control to compare the effects of tVNS and myofascial exercises. It differs from sham or placebo interventions used in oter studies because no active or stimalated treatment is provided.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Experimental | 10 sessions over 3 weeks; auricular stimulation of the vagus nerve using TENS; session duration 30 min. Receives: Device: Transcutaneous Vagus Nerve Stimulation; Other: Standard medical treatment |
| Myofascial Exercise Group | Experimental | 10 supervised sessions over 3 weeks; targeting cervical muscles. Receives: Behavioral: Myofascial Release Exercises; Other: Standard medical treatment |
| Control Group | No intervention | Standart Medical Care without additional inerventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tinnitus severity
Measured using the Tinnitus Handicap Inventory (THI), which assesses the impact of tinnitus on daily functioning.
Measured: Baseline to post-intervention (3 weeks)
Secondary outcomes (3)
Tinnitus Loudness
Assessed using Visual Analogue Scale for Tinnitus (VAS)
Measured: Baseline to post-intervention (3 weeks)
Sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI).
Measured: Baseline to post-intervention (3 weeks)
Audiometric measures
Pure-tone audiometry to assess hearing tresholds across frequencies
Measured: Baseline to post-intervention (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start17 Apr 2025
- Primary completion25 Sep 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic TinnitusStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- This is a three-arm, parallel group randomized controlled trial comparing the effects of transcutaneous vagus nerve stimulation (tVNS), myofascial release exercise, and standart medical care on chronic subjective tinnitus. Participants are randomly assigned to one of three groups and receive their assigned intervanetion to evaluate changes in tinnitus severity, sleep quality and audiometric measures.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria SARIKIR, Necmettin Erbakan University
- Investigators
- Neslihan ALTUNTAŞ YILMAZ, PhD, Principal investigator, Necmettin Erbakan University Nezahat Kelesoglu Faculty of Health SciencesMehmet Akif DUNDAR, PhD, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155733
- Sponsor's protocol ID
- 23069
- Acronym
- TVNS-TINN
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographics, efficacy outcomes, safety data
Publications
Rocha CB, Sanchez TG. Efficacy of myofascial trigger point deactivation for tinnitus control. Braz J Otorhinolaryngol. 2012 Dec;78(6):21-6. doi: 10.5935/1808-8694.20120028.
PubMed 23306563Yakunina N, Nam EC. Direct and Transcutaneous Vagus Nerve Stimulation for Treatment of Tinnitus: A Scoping Review. Front Neurosci. 2021 May 28;15:680590. doi: 10.3389/fnins.2021.680590. eCollection 2021.
PubMed 34122002
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effectiveness Of Myofascial Release Exercises and Vagus Nerve Neuromodulation in Tinnitus Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07155733
- Acronym / sponsor ID
- TVNS-TINN / 23069
- Conditions
- Chronic Tinnitus, Subjective Tinnitus, Neuromodulation
- Keywords
- tinnitus, chronic tinnitus, subjective tinnitus, vagus nerve stimulation, Transcutaneous Vagus Nerve Stimulation (tVNS), Auricular Vagus Nerve Stimulation, Neuromodulation, Myofascial Release
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 4 Sep 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.
This randomized controlled trial aims to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises in patient wiht chronic subjective tinnitus. Participants will be randomly assigned into three groups: (1) tVNS group, (2) Myofascial exercise group, and (3) Control group receiving standart medical care. The primary outcome is change in tinnitus severity measured by the Tinnitus Handicap Inventory (THI). Secondary outcomes include tinnitus loudness Visual Analouge Scale for Tinnitus (VAS), sleep quality Pitsburgh Sleep Quality Index (PSQI) and audiometric findings.
Detailed description
Tinnitus is a common and distressing condition that significantly impairs quality of life. Recent studies suggest that neuromdulation techniques such as vagus nerve stimulation and physical interventions targeting myofascial structures may reduce tinnitus severity. However, evidence remains limited, and comparative effectiveness of these approaches is not well established.
This single-center randomized controlled trial will compare the effects of transcutaneous vagus nerve stimulation (tVNS) and myofascial release exercises with a control group receiving only medical treatment. A total of 45 participants with chronic subjective tinnitus will be recruited. Participants will be randomized into three groups and receive 10 intervention sessions over three weeks.
The tVNS group will receive transcutaneous stimulation of the auricular branch of the vagus nerve using a TENS (Everyway N604, Taiwan) device. The myofascial group will undergo guided myofascial release targeting cervical muscles in addition to medical treatment. The control group will continue their medical treatment without additional interventions.
The primary outcome measure will be change in tinnitus-related handicap using the Tinnitus Handicap Inventory (THI). Secondary outcomes will include tinnitus loudness assesed by a Visual Analogue Scale for Tinnitus (VAS), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) and audiometric assesments.
The findings from this trial may provide new insights into non-farmacological rehabiliation strategies for tinnitus and clarify the role of neuromodulation compared with physical therapy inreventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-arm, parallel group randomized controlled trial comparing the effects of transcutaneous vagus nerve stimulation (tVNS), myofascial release exercise, and standart medical care on chronic subjective tinnitus. Participants are randomly assigned to one of three groups and receive their assigned intervanetion to evaluate changes in tinnitus severity, sleep quality and audiometric measures.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Experimental | Device: Transcutaneous Vagus Nerve Stimulation, Other: Standard medical treatment10 sessions over 3 weeks; auricular stimulation of the vagus nerve using TENS; session duration 30 min. |
| Myofascial Exercise Group | Experimental | Behavioral: Myofascial Release Exercises, Other: Standard medical treatment10 supervised sessions over 3 weeks; targeting cervical muscles. |
| Control Group | No intervention | –Standart Medical Care without additional inerventions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of chronic subjective tinnitus (>6 months)
- Ability to understand and provide written informed consent
- Willingness to comply with study procedures and intervention schedule
- Resistant for medical treatment for subjective tinnitus
- Impacted daily living by tinnitus
Key exclusion criteria (6 listed)
- Diagnoses such as auditory hallucinations, Meniere's disease, vestibular tumor, vertigo, or sudden hearing loss
- Trauma or surgical interventions involving the neck, jaw, or head within the 6 months
- Epilepsy or presence of a cardiac pacemaker (contraindication for tVNS)
- History of acute psychiatric disorders
- Use of ototoxic medications
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 StimulationParticipants receive 10 sessions of transcutaneous vagus nerve stimulation over 3 weeks using a TENS device. stimulation is applied to the auricular branch of the vagus nerve (cymba conchae/tragus) for 30 minutes per session. Participants continue usual medical care. Parameters (frequency, pulse width, intencity) are standartized according to safety guidelines. This intervention specifically targets the auricular branch of the vagus nerve, distinguishing it from other device-based intervention such as conventional TENS for pain management or non-auricular vagus stimulation used in other studies. | Device | Transcutaneous Vagus Nerve Stimulation |
| Myofascial Release ExercisesParticipants receive 10 supervised session over 3 weeks focusing on myofascial release of cervical muscles. in addition to their usual medical management for tinnitus. Exercises are designed to reduse muscle tensionpotentially contributing to tinnitus. This intervention is distinct from general physical therapy or standart relaxation exercises beacause it specifically targets myofascial structures implicated in tinnitus pathophysiology. | Behavioural | Myofascial Exercise Group |
| Standard medical treatmentParticipants continue their usual medical management for tinnitus without additional interventions. This group serves as a control to compare the effects of tVNS and myofascial exercises. It differs from sham or placebo interventions used in oter studies because no active or stimalated treatment is provided. | Other | Myofascial Exercise Group, Transcutaneous Vagus Nerve Stimulation |
Primary outcome
Change in tinnitus severity
Time frame: Baseline to post-intervention (3 weeks)
Measured using the Tinnitus Handicap Inventory (THI), which assesses the impact of tinnitus on daily functioning.
3 secondary outcomes
Tinnitus Loudness
Time frame: Baseline to post-intervention (3 weeks)
Sleep quality
Time frame: Baseline to post-intervention (3 weeks)
Audiometric measures
Time frame: Baseline to post-intervention (3 weeks)
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 4 Sep 2025.
- Background: PubMed 23306563Rocha CB, Sanchez TG. Efficacy of myofascial trigger point deactivation for tinnitus control. Braz J Otorhinolaryngol. 2012 Dec;78(6):21-6. doi: 10.5935/1808-8694.20120028.
- Background: PubMed 34122002Yakunina N, Nam EC. Direct and Transcutaneous Vagus Nerve Stimulation for Treatment of Tinnitus: A Scoping Review. Front Neurosci. 2021 May 28;15:680590. doi: 10.3389/fnins.2021.680590. eCollection 2021.
- This webpage provides information about Dr. Neslihan Altuntaş Yılmaz, a faculty member at the Department of Physiotherapy and Rehabilitation, Necmettin Erbakan University. Researchers interested in accessing individual participant data (IPD) from this clLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Demographics, efficacy outcomes, safety data
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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.
Neslihan ALTUNTAŞ YILMAZ, PhD principal investigator
Necmettin Erbakan University Nezahat Kelesoglu Faculty of Health Sciences
Mehmet Akif DUNDAR, PhD study director
Necmettin Erbakan 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 Vagus Nerve Stimulation, Myofascial Release Exercises and Standard medical treatment in people with Chronic Tinnitus and Subjective Tinnitus, run by Necmettin Erbakan 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 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 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?
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?
Change in tinnitus severity (time frame: Baseline to post-intervention (3 weeks)). 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 NCT07155733, which also lists 2 linked publications.
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 4 Sep 2025.