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临床试验/NCT06061458
NCT06061458尚未招募不适用

Assessment of Children With Variable Hearing Amplification Devices by Speech Auditory Brainstem Response

Assiut University0 个研究点目标入组 100 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
speech process in the groups

研究概览

简要总结

Assessment of children by speech auditory brainstem response which is an objective method to study the speech development

详细描述

Hearing loss in children can result in cognitive deficits in the central areas which are dependent upon hearing, therefore responsible for delay in speech development, poor language skills and disorders in psychological and mental behavior. It will also cause a decrease of the intellectual ability and socio-economic position of the child.

In children aged 3.5 years and older, pure tone audiometry is performed to determine the exact frequency-specific hearing threshold.

To obtain the auditory threshold in younger children, Skoe and Kraus reported that the auditory brainstem response has proven to be a clinically useful tool for assessing neural function at the brainstem level and is most commonly elicited by clicks or tone-bursts.

However, recent research has established that complex stimuli can also elicit the response such as Music, complex tones, and speech stimuli . A speech stimulus is particularly useful, as it can provide clues as to how temporal and spectral features are preserved in the brainstem.

The human soundscape is characterized by complex sounds with rich harmonic structure, dynamic amplitude modulations and rapid spectro-temporal fluctuations. This complexity is represented by temporal and spectral neural code within the auditory brainstem, two broad classes of time-locked responses can be defined namely transient and sustained responses .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • Control group: (25) Children with normal peripheral hearing bilaterally their age is matched with the study group.
  • Study group: three study groups, each study group has (25) children using, binaural Hearing aids, Cochlear implant and bimodal hearing with:
  • Average IQ.
  • No other congenital diseases affecting the speech progress.
  • Using the hearing device for at least one year.
  • Regular speech therapy sessions

排除标准

  • Any other children not fulfilling the inclusion criteria or refuse to participate in the study.

结局指标

主要结局

speech process in the groups

时间窗: 30 minutes after the test

presence of the waves in the test traces

次要结局

  • best hearing amplification device(30 minutes after the test)

研究者

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

kholoud omar, MD

Principle Investigator

Assiut University

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