跳至主要内容
临床试验/NCT04093830
NCT04093830Unknown不适用

Advantages of Bimodal Stimulation Compared to Unilateral Cochlear Implant Use in Children With Hearing Loss

Assiut University0 个研究点目标入组 25 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
主要终点
Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.

研究概览

简要总结

The majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural hearing loss .

详细描述

There are now many recipients of unilateral cochlear implants who have usable residual hearing in the non-implanted ear. To avoid auditory deprivation and to provide binaural hearing, a hearing aid or a second cochlear implant can be fitted to that ear. When bilateral cochlear implant cannot be used for patients with bilateral hearing impairment, a hearing aid can be used in their non- implanted ear with residual hearing. This is because patients with bilateral hearing loss need bilateral stimulation to develop the neural pathway required for central processing of binaural hearing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The lack of middle-ear infection.
  • Normative intelligence.
  • The lack of auditory neuropathy disorder .
  • Residual hearing in the non-implanted ear.

排除标准

  • Middle ear infection..
  • Below average intelligence.
  • Auditory neuropathy disorder.

结局指标

主要结局

Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.

时间窗: Baseline

The speech discrimination score is a measure as a percentage of words from a standardized list presented at suprathreshold levels that are recognized and repeated by the patient. a higher score on the speech discrimination test is better Interpreting speech discrimination score : 100-90% Means Excellent or Normal speech discrimination score, 89-75% Means Good speech discrimination score, 74-60% Means Fair speech discrimination score, 59-50 % Means Poor speech discrimination score\& \<50% Means Very Poor speech discrimination score.

Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition

时间窗: Baseline

By speech perception in noise (SPIN) test using Compact disc on compact discs player.

Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition

时间窗: Baseline

The test will be done starting from a low level using the manual and standard scoring forms of Early speech perception test ( ESP) by using : Compact disc , full-color picture cards, Toys ,digitally remastered sounds, and an All Words menu

Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.

时间窗: Baseline

Speech reception threshold is the minimum intensity in decibels at which a patient can understand 50% of spoken words from a closed set list of disyllabic words

Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition

时间窗: Baseline

By using pure tone and speech audiometer the pure tone audiometry will be done in the free field with a speaker at 0° azimuth and the mean threshold in speech frequencies of 0.5, 1, 2 and 4 kilohertz will be determined.

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

Mariam Rizk Fam

Resident doctor -Assiut university hospital-Assiut

Assiut University

相似试验