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临床试验/NCT04066270
NCT04066270Unknown不适用

Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates

Jessa Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
CT/MR of SCC

研究概览

简要总结

In 2014 radiological lesions at one or more semicircular canals (SCC) were described using CT & MR imaging in subjects presenting advanced hearing and vestibular deterioration caused by the p.P51S mutation in COCH. Similar lesions were also described in other non-genetic advanced hearing and vestibular deterioration as well. With this prospective observational study it is the purpose to inventory imaging results of candidates for cochlear implantation which are routinely performed during the preoperative work up, since these patient present severe hearing impairment at both ears. A considerable part of them might present vestibular deterioration as well. It is the purpose to detect possible presence of these SCC lesions on CT and MR in this population and the prevalence of these lesions compared to DFNA9 patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • must be eligible for cochlear implantation
  • must be 18 years of age or older

排除标准

  • <18 years of age
  • not eligible to undergo vestibular tests, especially videonystagmography
  • contra-indication for MR or CT

结局指标

主要结局

CT/MR of SCC

时间窗: at time of recruitment

lesions to one or more semicircular canals on CT and/or MR of temporal bone

p.P51S

时间窗: at time of recruitment

carriers hip of p.P51S mutation in COCH

次要结局

  • vestibular function 1(at time of recruitment)
  • vestibular function 2(at time of recruitment)
  • audiometry(at time of recruitment)
  • vestibular function 3(at time of recruitment)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastien Janssens de Varebeke

Principal Investigator

Jessa Hospital

研究点 (1)

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