Chronic Subjective TinnitusNCT07794462
Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
A study testing taVNS Combined With TMNMT in people with Chronic Subjective Tinnitus, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 6 sites in China.
Trial summary
The goal of this multicenter, randomized, double-blind clinical trial is to compare two treatments for adults with chronic subjective tinnitus. Researchers will determine whether transcutaneous auricular vagus nerve stimulation (taVNS) plus Tailor-Made Notched Music therapy (TMNMT) provides greater relief than the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Subjective Tinnitus
- What is being tested?
- taVNS Combined With TMNMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 6 sitesChina
- Study dates
- 1 Oct 2026to 30 Dec 2030
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with tinnitus as the primary chief complaint and the reason for seeking medical consultation.
- Patients with chronic subjective tinnitus duration of 6 months or longer.
- Age between 18 and 70 years.
- Tinnitus frequency within the range of 125-8000 Hz.
- Hearing threshold ≤ 70 dB HL.
- Tinnitus Handicap Inventory (THI) score ≥ 38.
Who cannot join
- Patients with conductive hearing loss, history of middle ear surgery, pulsatile tinnitus due to vascular malformations, or Meniere's disease-related tinnitus.
- History of head trauma, central nervous system disorders, or substance abuse/dependence. Patients with severe primary psychiatric disorders or acute episodes of severe psychological disturbances requiring priority specialist intervention. Patients with severe anxiety symptoms (Beck Anxiety Inventory [BAI] score ≥26), severe depressive symptoms (Beck Depression Inventory [BDI] score ≥29), or suicidal ideation identified during clinical interview will be excluded.
- Patients unwilling or unable to comply with study protocol requirements.
- Patients with peripheral auditory pathway or central space-occupying lesions identified by imaging, such as acoustic neuroma, middle ear cholesteatoma, or meningioma.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Qianhui Xu, MD, 13719908396, xuqh9@mail2.sysu.edu.cn
Huizhou First People's Hospital
Huizhou, Guangdong
Jia Fu, +86 15820715830, Jiaggfu1985@163.com
Jieyang People's Hospital
Jieyang, Guangdong
Jiongcong Yuan, +86 13480311910, jiongcongyuan@126.com
Eye & ENT Hospital, Fudan University
Shanghai
Shan Sun, 86+18917786102, Shansun@fudan.edu.cn
Zhongshan City People's Hospital
Zhongshan, Guangdong
Guoping Chen, 86+15019918918, cgping345@163.com
Zhuhai Integrated Traditional Chinese and Western Medicine Hospital
Zhuhai, Guangdong, 519000
Binbin Xiong, 86+13926935096, xiongbb2015@126.com
About this study
Official title: Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus: A Multicenter, Randomized, Double-Blind Controlled Clinical Trial
The goal of this multicenter, randomized, double-blind clinical trial is to compare two treatments for adults with chronic subjective tinnitus. Researchers will determine whether transcutaneous auricular vagus nerve stimulation (taVNS) plus Tailor-Made Notched Music therapy (TMNMT) provides greater relief than the same music therapy combined with sham taVNS.
A total of 444 participants aged 18 to 70 years will be enrolled at multiple study centers. Participants will be randomly assigned in a 1:1 ratio to receive taVNS plus TMNMT or sham taVNS plus the same TMNMT. The treatment period will last 3 months.
- Conditions
- Chronic Subjective Tinnitus
- Being tested
- taVNS Combined With TMNMT, Sham taVNS Combined With TMNMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNS Combined With TMNMTDevice
Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) combined with Tailor-Made Notched Music Therapy (TMNMT) for 3 months. taVNS is administered at 0.1 Hz, with a pulse width of 250-1000 ms and an intensity of 0-0.5 mA.
Sham taVNS Combined With TMNMTDevice
Participants receive sham transcutaneous auricular vagus nerve stimulation (sham taVNS) combined with Tailor-Made Notched Music Therapy (TMNMT) for 3 months. The initial sham stimulation parameters are 0.1 Hz, a pulse width of 250-1000 ms, and an intensity of 0-0.5 mA.
| Study group | Role | What they receive |
|---|---|---|
| taVNS + TMNMT Group | Experimental | Participants receive active transcutaneous auricular vagus nerve stimulation (taVNS) combined with Tailor-Made Notched Music therapy (TMNMT) for 3 months. taVNS is administered at 0.1 Hz, with a pulse width of 250-1000 ms and an intensity of 0-0.5 mA. Receives: Device: taVNS Combined With TMNMT |
| Sham taVNS + TMNMT Group | Sham comparator | Participants receive sham transcutaneous auricular vagus nerve stimulation (taVNS) combined with the same Tailor-Made Notched Music therapy (TMNMT) as the experimental arm for 3 months. The initial sham stimulation parameters are 0.1 Hz, a pulse width of 250-1000 ms, and an intensity of 0-0.5 mA. Receives: Device: Sham taVNS Combined With TMNMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Rate of Tinnitus Improvement at 3 Months
Treatment response was defined as a reduction of ≥7 points in the THI score from baseline after 3 months of treatment (based on the internationally recognized minimal clinically important difference threshold). Effective rate (%) = (Number of responders / Total number of patients in the corresponding group) x 100%.
Measured: Baseline and 3 months after treatment initiation
Secondary outcomes (9)
Effective Rate of Tinnitus Improvement at 6 and 12 Months
Treatment response was defined as a reduction of ≥7 points in the THI score from baseline after 6 and 12 months of treatment (based on the internationally recognized minimal clinically important difference threshold). Effective rate (%) = (Number of responders / Total number of patients in the corresponding group) x 100%.
Measured: Baseline, 6 months, and 12 months after treatment initiation
Change in Visual Analog Scale (VAS) Score for Tinnitus Loudness
Change in tinnitus loudness assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 (barely perceptible) to 10 (unbearably loud). The change score (ΔVAS) is calculated as the difference between post-treatment/follow-up scores and baseline. Higher scores indicate greater perceived loudness; a decrease in VAS score indicates improvement in loudness perception.
Measured: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Acoustic Tinnitus Match Loudness
Change in acoustic tinnitus match loudness assessed using a calibrated audiometer in a standard sound-proof environment. The change in loudness threshold is calculated relative to baseline. Assessment method: audiologist-assessed.
Measured: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Beck Anxiety Inventory (BAI) Score
Change in anxiety symptoms assessed using the Beck Anxiety Inventory (BAI), a 21-item self-reported questionnaire measuring the severity of anxiety symptoms over the past week. Higher scores indicate greater anxiety severity. The change score (ΔBAI) is calculated as the difference between post-treatment/follow-up scores and baseline. Assessment method: self-reported.
Measured: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Beck Depression Inventory (BDI) Score
Change in depressive symptoms assessed using the Beck Depression Inventory (BDI). The change score (ΔBDI) is calculated as the difference between post-treatment/follow-up scores and baseline.
Measured: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The change score (ΔPSQI) is calculated as the difference between post-treatment/follow-up scores and baseline. Assessment method: self-reported.
Measured: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Resting-State EEG Features
Change in resting-state EEG features, including power spectrum entropy and oscillatory characteristics, from baseline to post-treatment and follow-up.
Measured: Baseline, 3 months, and 6 months after treatment initiation
Change in MRI Features
Change in MRI features from baseline to post-treatment and follow-up.
Measured: Baseline, 3 months, and 6 months after treatment initiation
Safety Outcomes: Incidence of Treatment-Related Adverse Events
Incidence of treatment-related adverse events, including auditory system-related events (e.g., ear canal or auricle burns, otalgia, hearing loss, tinnitus worsening) and non-auditory system-related events (e.g., dizziness, headache, palpitations, vomiting) occurring during the treatment period. Adverse event rate (%) = (Number of patients experiencing treatment-related adverse events / Total number of patients receiving treatment) × 100%.
Measured: From treatment initiation through 3 months (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subjective TinnitusStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuexin Cai, Doctor, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794462
- Sponsor's protocol ID
- SYSKY-2025-917-02
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus: A Multicenter, Randomized, Double-Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07794462
- Acronym / sponsor ID
- SYSKY-2025-917-02
- Conditions
- Chronic Subjective Tinnitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 31 Aug 2026 (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 multicenter, randomized, double-blind clinical trial is to compare two treatments for adults with chronic subjective tinnitus. Researchers will determine whether transcutaneous auricular vagus nerve stimulation (taVNS) plus Tailor-Made Notched Music therapy (TMNMT) provides greater relief than the same music therapy combined with sham taVNS.
A total of 444 participants aged 18 to 70 years will be enrolled at multiple study centers. Participants will be randomly assigned in a 1:1 ratio to receive taVNS plus TMNMT or sham taVNS plus the same TMNMT. The treatment period will last 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS + TMNMT Group | Experimental | Device: taVNS Combined With TMNMTParticipants receive active transcutaneous auricular vagus nerve stimulation (taVNS) combined with Tailor-Made Notched Music therapy (TMNMT) for 3 months. taVNS is administered at 0.1 Hz, with a pulse width of 250-1000 ms and an intensity of 0-0.5 mA. |
| Sham taVNS + TMNMT Group | Sham comparator | Device: Sham taVNS Combined With TMNMTParticipants receive sham transcutaneous auricular vagus nerve stimulation (taVNS) combined with the same Tailor-Made Notched Music therapy (TMNMT) as the experimental arm for 3 months. The initial sham stimulation parameters are 0.1 Hz, a pulse width of 250-1000 ms, and an intensity of 0-0.5 mA. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with tinnitus as the primary chief complaint and the reason for seeking medical consultation.
- Patients with chronic subjective tinnitus duration of 6 months or longer.
- Age between 18 and 70 years.
- Tinnitus frequency within the range of 125-8000 Hz.
- Hearing threshold ≤ 70 dB HL.
Key exclusion criteria (4 listed)
- Patients with conductive hearing loss, history of middle ear surgery, pulsatile tinnitus due to vascular malformations, or Meniere's disease-related tinnitus.
- History of head trauma, central nervous system disorders, or substance abuse/dependence. Patients with severe primary psychiatric disorders or acute episodes of severe psychological disturbances requiring priority specialist intervention. Patients with severe anxiety symptoms (Beck Anxiety Inventory [BAI] score ≥26), severe depressive symptoms (Beck Depression Inventory [BDI] score ≥29), or suicidal ideation identified during clinical interview will be excluded.
- Patients unwilling or unable to comply with study protocol requirements.
- Patients with peripheral auditory pathway or central space-occupying lesions identified by imaging, such as acoustic neuroma, middle ear cholesteatoma, or meningioma.
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 |
|---|---|---|
| taVNS Combined With TMNMTParticipants receive transcutaneous auricular vagus nerve stimulation (taVNS) combined with Tailor-Made Notched Music Therapy (TMNMT) for 3 months. taVNS is administered at 0.1 Hz, with a pulse width of 250-1000 ms and an intensity of 0-0.5 mA. | Device | taVNS + TMNMT Group |
| Sham taVNS Combined With TMNMTParticipants receive sham transcutaneous auricular vagus nerve stimulation (sham taVNS) combined with Tailor-Made Notched Music Therapy (TMNMT) for 3 months. The initial sham stimulation parameters are 0.1 Hz, a pulse width of 250-1000 ms, and an intensity of 0-0.5 mA. | Device | Sham taVNS + TMNMT Group |
Primary outcome
Effective Rate of Tinnitus Improvement at 3 Months
Time frame: Baseline and 3 months after treatment initiation
Treatment response was defined as a reduction of ≥7 points in the THI score from baseline after 3 months of treatment (based on the internationally recognized minimal clinically important difference threshold). Effective rate (%) = (Number of responders / Total number of patients in the corresponding group) x 100%.
9 secondary outcomes
Effective Rate of Tinnitus Improvement at 6 and 12 Months
Time frame: Baseline, 6 months, and 12 months after treatment initiation
Change in Visual Analog Scale (VAS) Score for Tinnitus Loudness
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Acoustic Tinnitus Match Loudness
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Beck Anxiety Inventory (BAI) Score
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Beck Depression Inventory (BDI) Score
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, 3 months, 6 months, and 12 months after treatment initiation
Change in Resting-State EEG Features
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Change in MRI Features
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Safety Outcomes: Incidence of Treatment-Related Adverse Events
Time frame: From treatment initiation through 3 months (end of treatment)
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 31 Aug 2026.
- 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.
Yuexin Cai, Doctor study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS Combined With TMNMT in people with Chronic Subjective Tinnitus, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 6 sites in China.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
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 Yuexin Cai, Doctor (86+13825063663, caiyx25@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Rate of Tinnitus Improvement at 3 Months (time frame: Baseline and 3 months after treatment initiation). 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 31 Aug 2026.