Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Video head impulse test (VHIT)
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 enrolled 231 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, 3 months, 6 months, and 12 months. Video head impulse test (VHIT), the caloric test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 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.
研究组 & 干预措施
Control group
干预措施: Betahistine Mesylate tablet (Drug)
taVNS group
干预措施: taVNS (Device)
taVNS group
干预措施: Betahistine Mesylate tablet (Drug)
sham taVNS group
干预措施: taVNS (Device)
sham taVNS group
干预措施: Betahistine Mesylate tablet (Drug)
结局指标
主要结局
Video head impulse test (VHIT)
时间窗: Baseline, month 3, 6 and 12
VHIT was used to assess the function of all the six SCCs by measuring the gain of the vestibulo-ocular reflex. The instrument comprises an inertial measurement unit to measure movements of the head and an infrared camera to record eye movements. HIT can calculate the mean gain value (ratio of eye to head velocity) for each of the six SCCs, and also detect covert or overt saccades. During the test, goggles were secured firmly to patients' head to ensure that the goggles did not slip from the face during head movement. Patients sat \~1.5 m in front of a wall on which a visual target was affixed. Before testing, head movement and eye movement were calibrated according to the manufacturer's instructions. According to manufacture recommendations, normal gain values are expected to range between 0.80 and 1.20 for horizontal canals, and 0.70-1.20 for vertical canals. Pathological saccades and gain values below the normal range were recorded.
次要结局
- Tinnitus Handicap Inventory (THI)(Baseline, month 3, 6 and 12)
- Visual analogue scale (VAS)(Baseline, month 3, 6 and 12)
- Dizziness Handicap Inventory (DHI)(Baseline, month 3, 6 and 12)
- The caloric test(Baseline, month 3, 6 and 12)
- Pure tone thresholds(Baseline, month 3, 6 and 12)