Vestibular Function Evaluated by the Video Head Impulse Test (vHIT) and Vertigo Perceived by the Patients Before and After Cochlear Implant Surgery.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Vestibular function
研究概览
简要总结
This study investigate weather one type of cochlear implant (CI) surgery (insertion of the electrode via paracentesis of the round window (RWA)) leads to less vertigo than another type of CI surgery (cochleostomy). The participants will be randomized into 2 groups: RWA or cochleostomy. They will be examined with a video head impulse test (vHIT) before and after CI surgery to clarify their vestibular function.
详细描述
Cochlear implant is an advanced type of hearing advice. It consists of an outer microphone, which picks up sound and sends it through an electrode into the cochlear.
With a cochlear implant people, that are profoundly deaf or have severe hearing loss, can get their hearing back.
Vertigo is one of the most common side effects to cochlear implant surgery. In this study we will investigate if one type of CI surgery (insertion of the electrode via paracentesis of the round window) leads to less vertigo than another type of CI surgery (cochleostomy).
In the randomization there will be stratified according to age (60+/-), residual hearing (yes/no) and gain before surgery (+/-0,68). Three different surgeons will do the surgeries. All technical aspect of the surgery, other than the insertion of the electrode into cochlea, is being done identically.
Electrodes from Cochlear, MEDEL and AB is being used. We will compare the findings from the vHIT examination with the subject dizziness perceived of the patient.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •deaf or severe hard of hearing
- •normal or slightly affected vestibular function (gain >0,50)
排除标准
- •subjects with otosclerosis
- •subject who will have the CI surgery for preservation of the residual hearing
研究组 & 干预措施
Cochleostomy
In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).
干预措施: Cochleostomy (Procedure)
Round window approach
In this group the insertion of the electrode into cochlea will be performed through an incision in the membrane (paracentesis) of the round window (round window approach = RWA)
干预措施: Round window approach (Procedure)
结局指标
主要结局
Vestibular function
时间窗: 1 month
Measured by video head impulse test one month after CI surgery in connection with consultation for CI activation
次要结局
- Subjective dizziness(1 month)
- Dizziness(1 month)
- T level(1 month)
- NRT level(1 month)
- C level(1 month)
- Dizziness(1 day)
研究者
Leise Elisabeth Hviid Korsager
BSc
Odense University Hospital