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临床试验/NCT02574299
NCT02574299已完成不适用

Characterization of Ascending and Descending Auditory Processing Involved in the Encoding of Speech Sounds in Adult and Children: Variability Related to Changes in Sensory Input or a Neurodevelopmental Disorder or Targeted Remediation

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Change from Baseline speech auditory brainstem and late responses (composite and objective measure) in response to syllables (behavioral measure)

研究概览

简要总结

The ability to encode the speech signal is determined by ascending and descending auditory processing. Difficulties in processing these speech signals are well described at the behavioral level in a specific language disorder. However, little is known about the underlying pathophysiological mechanisms. The assumption is that we should observe a degradation of the signal provided by the ear in the deaf subject while in case of specific language impairment it would be a phonemic disorder (possibly linked to a processing disorder auditory). The two population groups should therefore have different abnormalities of their central auditory process - which could be modified by the target remediation for each group.

研究设计

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

入排标准

年龄范围
6 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •For all subjects:
  • •native French speaker
  • •no medical treatment for behavior or neurological disorders
  • •normal or corrected vision
  • •right-handed
  • •normal otorhinolaryngology examination
  • •valid affiliation to social security
  • •no participation to another research study
  • •For the normal-hearing subjects
  • •normal tonal hearing thresholds
  • •normal tympanometry
  • •For the subjects without specific language impairment
  • •aged from 6 ro 40
  • •normal school attendance without scholastic retardation
  • •normal intellectual level
  • •normal for age reading skills
  • •no delayed speech (expression & production)
  • •For the children with specific language impairment
  • •aged fom 8 to 18
  • •persistent specific literacy difficulties with reading levels at least 18 months behind that of their peers
  • •normal intellectual level
  • •For the hearing impaired subjects
  • •age from 18 to 70
  • •first auditory rehabilitation
  • •bilateral and symmetric hearing loss (±10 dB) with hearing thresholds between 0 and 25 dB at 0.25 kilohertz, 0 and 35 dB at 0.5 kilohertz, 0 and 50 dB at 1 kilohertz, 25 and 70 dB at 2 kilohertz, 25 and 80 dB at 3 kilohertz, 30 and 80 dB at 4 kilohertz

排除标准

  • •non signed assent
  • •treatment for depression, epilepsy, Parkinson's or alzheimer's disease during more than 6 months
  • •physical health deficiency
  • •mental retardation
  • •neurological or psychiatric disease incompatible with testing procedure
  • •For children
  • •known problem of hearing loss or chronic middle ear disease whic compromized the hearing status
  • •schooling in a foreign language
  • •foreign language spoken at home with both parents

研究组 & 干预措施

1: Normal hearing children without SLI, transversal group

No Intervention

Normal hearing children without Specific Language Impairment (SLI),Transversal group for test-retest measures

2: Normal hearing children without SLI, longitudinal group

No Intervention

Normal hearing children without Specific Language Impairment (SLI), longitudinal group without training

3: Normal hearing children with SLI, longitudinal group

Other

Normal hearing children with Specific Language Impairment (SLI), longitudinal group with training

干预措施: E-learning (Other)

4: Normal hearing adults without SLI, transversal group

No Intervention

Normal hearing adults without Specific Language Impairment (SLI), transversal group for test-retest measures

5: Normal hearing adults without SLI, longitudinal group

No Intervention

Normal hearing adults without Specific Language Impairment (SLI), longitudinal group without hearing aids (HA)

6: Hearing Impaired candidates for HA, longitudinal group

Other

Hearing Impaired adult candidates for hearing aids (HA), longitudinal group with hearing aids (HA)

干预措施: Hearing aids fitting (Device)

结局指标

主要结局

Change from Baseline speech auditory brainstem and late responses (composite and objective measure) in response to syllables (behavioral measure)

时间窗: Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline

Spectro-temporal analysis of speech auditory brainstem and late responses : The speech brainstem and cortical responses are simultaneously obtained in response of different selected syllables from a continuum (selected by using a phonemic identification test) which is presented throughout a behavioral categorical procedure

次要结局

  • Change from Baseline medial olivocochlear system (MOCS) functioning measured using the contralateral suppressive effect of transient evoked otoacoustic emissions (composite measure)(Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline)
  • Change from Baseline speech-noise listening skills measured using logatomes tests (composite measure)(Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline)
  • Change from Baseline dichotic skills measured using central auditory processing tests (composite measure)(Arms 2 and 3: Baseline and 5 weeks / Arms 5 and 6: Baseline and 6 months / Arms 1 and 4: Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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