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临床试验/NCT00167128
NCT00167128Unknown不适用

The Phonak EduLink-System in Students With Specific Performance Deficits in Speech-in-Noise Intelligibility

University Hospital Muenster2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2005年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
auditory performance

研究概览

简要总结

In the management and remediation of students with specific performance deficits in speech-in-noise intelligibility, most often, a "triad" approach for treatment is used, which includes direct therapy, compensatory strategies, and environmental modifications.

The purpose of the study is to determine whether a new hearing aid, the Phonak EduLink-FM System, can improve specific performance deficits in speech-in-noise intelligibility. Participants will complete a test battery related to auditory processing, as well as some psychological tests and questionnaires. One group of participants with specific performance deficits in speech-in-noise intelligibility will receive the hearing aid for use in school; a second group will not. The effect of this treatment on auditory performance, school performance and satisfaction, attention and verbal learning and memory, self concept, behavior and listening effort following 26 weeks of hearing aid use will be compared across the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of specific performance deficits in speech-in-noise intelligibility based on two or more standardized tests of auditory processing in noise including retests.
  • •Students in the 1st to 4th class of primary school

排除标准

  • •Hearing loss, defined as:
  • •Air conduction pure tone thresholds (250-8000 Hz) exceeding 20 dBHL
  • •Air-bone gaps, even in the presence of normal sensitivity, exceeding 10 dBHL
  • •Abnormal tympanogram
  • •History or diagnosis of behavioral and/or emotional disorders meeting ICD-GM-criteria (including attention deficit/hyperactivity disorders (AD-/HD)
  • •Non-German speaking
  • •Cognitively impaired children (IQ < 85)
  • •Children currently using psychoactive medication
  • •Students with special education

结局指标

主要结局

auditory performance

时间窗: following 26 weeks hearing aid use

school performance and satisfaction

时间窗: following 26 weeks hearing aid use

attention

时间窗: following 26 weeks hearing aid use

verbal learning and memory

时间窗: following 26 weeks hearing aid use

次要结局

  • self concept(following 26 weeks hearing aid use)
  • behavior(following 26 weeks hearing aid use)
  • listening effort(following 26 weeks hearing aid use)

研究者

发起方
University Hospital Muenster
申办方类型
Other

研究点 (2)

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