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临床试验/NCT03738592
NCT03738592已完成不适用

Spatial Hearing Perception in Bilateral Cochlear Implant Children

Hospices Civils de Lyon4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年1月24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
36
试验地点
4
主要终点
measure of the spatial hearing deficit matching the distance between the hand pointing error and the sound source position in space

研究概览

简要总结

Spatial hearing in cochlear implant (CI) users is a challenging investigation field since no studies have explored yet spatial auditory perception in three-dimensional space (3D). Moreover auditory rehabilitation after cochlear implantation is totally devoted to speech rehabilitation to date.

A novel methodology based on virtual reality and 3D motion capture protocol in an immersive reality system has recently been developed to evaluate and record spatial hearing abilities of norm-hearing (NH) listeners and CI adults in 3D. The results revealed worse sound localization in 3D for CI users compared to NH participants, and interestingly noted that head movements could improve sound localization performances, leading to a possible track for auditory rehabilitation.

The aim of this study is to explore spatial hearing in CI children with the protocol already tested in CI adults. This protocol will be adapted to children over eight years old. Children will have to perform a sound localization task in 3D without any feedback of performances. The knowledge improvement in pediatric sound localization will lead to develop a specific spatial rehabilitation in cochlear implant children.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •for cochlear implant children:
  • •Age between 8 and 17 included
  • •second cochlear implant issued within more than 2 years
  • •mean speech recognition over 80% with two cochlear implants
  • •normal visual acuity with or without correction
  • •abilities to understand experimental instructions
  • •a consent form signed by parents or guardian
  • •registered with a social security scheme

排除标准

  • •for cochlear implant children:
  • •neurologic or psychiatric trouble
  • •visual trouble
  • •bilateral vestibular areflexia
  • •Inclusion Criteria for normal hearing children:
  • •Age between 8 and 17 included
  • •normal visual acuity with or without correction
  • •abilities to understand experimental instructions
  • •a consent form signed by parents or guardian
  • •registered with a social security scheme
  • •Exclusion Criteria for normal hearing children:
  • •neurologic or psychiatric trouble
  • •visual trouble
  • •bilateral vestibular areflexia

研究组 & 干预措施

cochlear implant children

Experimental

18 cochlear implant children wil include in this study

干预措施: behavioral exploration of spatial hearing performances (Other)

cochlear implant children

Experimental

18 cochlear implant children wil include in this study

干预措施: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents) (Other)

cochlear implant children

Experimental

18 cochlear implant children wil include in this study

干预措施: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children) (Other)

normal hearing children

Other

18 normal hearing children wil include in this study

干预措施: behavioral exploration of spatial hearing performances (Other)

结局指标

主要结局

measure of the spatial hearing deficit matching the distance between the hand pointing error and the sound source position in space

时间窗: thirty minutes

Data from spatial sound perception will be recorded in three dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error "D", hence summarizing all three dimensions of space, and taking into account absolute and variable error in one measure.

次要结局

  • change of the pupil diameter during a sound localization task(thirty minutes)
  • impact of age at cochlear implantation on spatial hearing deficit(thirty minutes)
  • correlation between a clinical score (SSQ) and sound localization performances(28 days)
  • measure of head and eye movements in three dimensional space with a motion tracking system (virtual reality system including a Head-Mounted display) to evaluate their roles in spatial hearing performances.(thirty minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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