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临床试验/NCT02948790
NCT02948790已完成不适用

Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study

Oticon Medical4 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
4
主要终点
Wave V latency

研究概览

简要总结

The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.

详细描述

Whatever the acoustic neuroma treatments, the patient risks a hearing loss. The global strategy of hearing care aims to preserve the quality of life and patient hearing. For severe to profound hearing loss and anatomical auditory nerve preservation, the cochlear implant is put forward compared to the auditory brainstem implant. Indeed, cochlear implant provides better speech outcomes. If cochlear implantation is not possible or no benefit for the patient, the brainstem implant is the most widely used. The Neuristim device is used to investigate the auditory nerve integrity following neuroma surgery or on an affected auditory nerve. The Neuristim is an intra-cochlear stimulator used in an intraoperative way. The intra-cochlear electrodes provide an electrical stimulation to auditory nerve fibers, and auditory nerve response measurements to these electrical stimulation are recorded and evaluated to determine the auditory nerve functionality. The Neuristim is a device for helping surgeons to choose the most appropriate implantable solution. 2 groups of patients will be involved in this study:

  • a group of 17 patients with an acoustic neuroma or a past neuroma surgically removed or acoustic neuroma not requiring a surgery and with severe to profound hearing loss candidate for a cochlear implant or a auditory brainstem depending on the auditory nerve functionality,
  • a group of 17 patients with severe to profound hearing loss candidate for a cochlear implant.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be 18 years or older
  • Patient with an acoustic neuroma already surgically removed with associated hearing loss (experimental group),
  • Patient with an acoustic neuroma programmed to be surgically removed and candidates for an implantable hearing rehabilitation solution (experimental group),
  • Patient with an acoustic neuroma that not need to be removed and candidate for an implantable hearing rehabilitation solution (experimental group), or
  • Typical patient candidate for a cochlear implant (control group)

排除标准

  • Cochlea malformation, cochlea ossification
  • Vulnerable subject

结局指标

主要结局

Wave V latency

时间窗: perioperatively

次要结局

  • Complications(perioperatively, 15 days postoperatively)
  • Impedance measurement(perioperatively)
  • ergonomics of the Neuristim(perioperatively)
  • Speech audiometry(3 months postoperatively)
  • Pure tone audiometry(3 months postoperatively)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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