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临床试验/CTRI/2020/04/024686
CTRI/2020/04/024686尚未招募不适用

Residual hearing following cochlear implantation: An observational study

Jipmer Pondicherry1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年4月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
49
试验地点
1
主要终点
Residual hearing preservation using the Skarzynski formula.

研究概览

简要总结

  1. Title: Residual hearing following cochlear implantation: An observational study

  2. Research hypothesis: a. Cochlear implantation causes damage to the residual hearing

b. There is a negative correlation between depth of insertion of a cochlear implant and residual hearing.

  1. Primary objective: To evaluate residual hearing after cochlear implantation.

  2. Secondary objective: To correlate depth of insertion of electrode array and residual hearing.

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • All children who have undergone cochlear implantation at least 6 months before the day of assessment.

排除标准

  • Cochlear implantation done for anatomically abnormal cochlea
  • Children who have undergone a revision cochlear implant in the same ear.
  • Children unable to understand commands for pure tone audiometry.

结局指标

主要结局

Residual hearing preservation using the Skarzynski formula.

时间窗: June 2020

次要结局

  • To determine the optimum length of electrode array needed to provide electrical stimulation without damage to the residual hearing.(June 2020)

研究者

发起方
Jipmer Pondicherry
申办方类型
Research institution and hospital

研究点 (1)

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