跳至主要内容
临床试验/NCT03745534
NCT03745534招募中不适用

Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study

Christoph Arnoldner1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
8
试验地点
1
主要终点
eABR correlation

研究概览

简要总结

Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.

详细描述

Patients treated with radio surgery for vestibular schwannoma often suffer from hearing loss. Especially when the contralateral side has progressive hearing loss assessment if cochlear implantation is feasible, should be carried out. Patients undergo extensive audiometric testing. Additionally, patients will undergo preoperative eABR. Intraoperatively eABR is carried out and cochlear implantation is performed. The eABR results will be correlated with postoperative hearing. EABR measurements are not part of the study. The results of eBAR will be categorized in three groups (good response, weak response and no response). The eABR results will then be correlated to speech understanding with cochlear implants measured with Freiburger monosyllables test.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Patients who have undergone radio surgery for vestibular schwannoma
  • Patients wanting cochlear implantation for hearing rehabilitation

排除标准

  • Patients not wanting to participate in the study

结局指标

主要结局

eABR correlation

时间窗: 2 years

eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response Hearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB

次要结局

未报告次要终点

研究者

发起方
Christoph Arnoldner
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christoph Arnoldner

Assoc Prof PD. Dr.

Medical University of Vienna

研究点 (1)

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