Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Meniere Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
研究概览
简要总结
Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease.
Methods: We accrued 25 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks.
Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects.
A difference of P < 0.05 was considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18 and Age <=
- •Clinical diagnosis of meniere disease.
排除标准
- •History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
- •History of Otorhinolaryngology surgery.
- •Pregnant or lactating women.
结局指标
主要结局
Mean change from Baseline in the Tinnitus Handicap Inventory (THI) rating scale at 12 Weeks
时间窗: Day 0 and postintervention at Week 12
Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms. Tinnitus Handicap Inventory (THI) to measure the subjective tinnitus symptoms
Mean change from Baseline in the Pure Tone Audiometry at 12 Weeks
时间窗: Day 0 and postintervention at Week 12
Pure Tone Audiometry to measure the audition.
Mean change from Baseline in the Dizziness Handicap Inventory (DHI) at 12 Weeks
时间窗: Day 0 and postintervention at Week 12
DHI to measure the subjective dizziness symptoms.
次要结局
- Mean change from Baseline in the visual scale of ear stuffiness at 12 Weeks(Day 0 and postintervention at Week 12)
- Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks(Day 0 and postintervention at Week 12)