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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 444
- 试验地点
- 6
- 主要终点
- Effective Rate of Tinnitus Improvement at 3 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
taVNS + TMNMT Group
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.
干预措施: taVNS Combined With TMNMT (Device)
Sham taVNS + TMNMT Group
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.
干预措施: Sham taVNS Combined With TMNMT (Device)
结局指标
主要结局
Effective Rate of Tinnitus Improvement at 3 Months
时间窗: 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%.
次要结局
- Effective Rate of Tinnitus Improvement at 6 and 12 Months(Baseline, 6 months, and 12 months after treatment initiation)
- Change in Visual Analog Scale (VAS) Score for Tinnitus Loudness(Baseline, 3 months, 6 months, and 12 months after treatment initiation)
- Change in Acoustic Tinnitus Match Loudness(Baseline, 3 months, 6 months, and 12 months after treatment initiation)
- Change in Beck Anxiety Inventory (BAI) Score(Baseline, 3 months, 6 months, and 12 months after treatment initiation)
- Change in Beck Depression Inventory (BDI) Score(Baseline, 3 months, 6 months, and 12 months after treatment initiation)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, 3 months, 6 months, and 12 months after treatment initiation)
- Change in Resting-State EEG Features(Baseline, 3 months, and 6 months after treatment initiation)
- Change in MRI Features(Baseline, 3 months, and 6 months after treatment initiation)
- Safety Outcomes: Incidence of Treatment-Related Adverse Events(From treatment initiation through 3 months (end of treatment))