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临床试验/CTRI/2024/11/077390
CTRI/2024/11/077390尚未招募不适用

Correlation of Auditory and Speech Outcome with Electrode Modiolus distance after Cochlear Implantaton in Children with Prelingual deafness

Research Section All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年12月2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
52
试验地点
1
主要终点
Auditory and verbal outcomes as measured by aided audiogram, ASSR and CAP & SIR scores respectively after 12 months

研究概览

简要总结

Pre lingual deaf children undergoing cochlear implantation surgery.Complete clinical, audiological & radiological evaluation;

*Cochlear morphology & parameters will done for individual child.Cochlear implantation will done.Radiologic assessment of EMD of 1st, 6th & 12th electrode done post operatively.Assessment of audiological outcomes by aided audiogram & ASSR,

Speech outcomes by CAP & SIR scores at 12 months;

Correlation between EMD and outcomes will done.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Pre lingual deaf children undergoing cochlear implantation surgery in All India Institute of Medical Sciences, Jodhpur.

排除标准

  • Inner ear anomalies
  • History of middle or inner ear surgery
  • Contraindication or difficulty for undergoing postoperative radiology
  • Parents or guardian not willing for the study.

结局指标

主要结局

Auditory and verbal outcomes as measured by aided audiogram, ASSR and CAP & SIR scores respectively after 12 months

时间窗: 1 year

次要结局

  • explore potential factors influencing electrode-modiolar distance including cochlear parameters, round window variation and method of insertion(1 year)

研究者

发起方
Research Section All India Institute of Medical Sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sindhamani M

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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