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临床试验/NCT03719963
NCT03719963Unknown不适用

Preoperative Variables Affecting Outcome Of Cochlear Implant

Assiut University0 个研究点目标入组 40 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
speech cortical evoked potential

研究概览

简要总结

Cochlear implants (CIs) represent one of the most important achievements of modern medicine as, for the first time in history, an electronic device is able to restore a lost sense - hearing. As of December 2012, approximately 324,200 cochlear implants have been implanted worldwide. In the United States, roughly 58,000 devices have been implanted in adults and 38,000 in children .

The aim of this study is to assess the factors affecting the audiological, speech and language outcomes achieved by the recipients of multi-channel cochlear implants.

详细描述

Cochlear implants (CIs) represent one of the most important achievements of modern medicine as, for the first time in history, an electronic device is able to restore a lost sense - hearing. As of December 2012, approximately 324,200 cochlear implants have been implanted worldwide. In the United States, roughly 58,000 devices have been implanted in adults and 38,000 in children .

Cochlear implantation is a powerful tool for helping children with severe to profound sensorineural hearing loss to gain the ability to hear, and to achieve age appropriate communication skills. Evaluating the development of auditory, speech, language skills and the personality of implanted child is useful for the parent, the teacher, the therapist, and the subsequent rehabilitation progress .

However the final outcome in pediatric implantation is yet not entirely predictable as there are a large number of factors which alone or in combination will decide the outcome of cochlear implantation.

Categorizing these determinants increases the ability of clinicians to offer educated preoperative prognosis and might potentially allow for manipulation of variables in an attempt to achieve the best possible outcome .

Before implantation, a trial period with appropriate amplification combined with intensive auditory training should be attempted to ensure that maximal benefit is achieved.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • a) Children with bilateral severe to profound sensorineural hearing loss. b) Age less than 6 years at time of implantation. c) Prelingual deafness

排除标准

  • Incomplete follow up.
  • post lingual children
  • children with special needs such as mental retardation or autism

结局指标

主要结局

speech cortical evoked potential

时间窗: 1 year

Intelligent hearing system is the name of the instrument that will be used,speech stimulus that will used,cortical p1 and N1 waves that will be detected which is the outcome that we need to measure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nashwa Ameer Mahmoud Mesaed

principle investigator

Assiut University

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