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临床试验/NCT06420921
NCT06420921尚未招募不适用

MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

Institut Pasteur2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
2
主要终点
percentage of environmental sound cues correctly identified when presented simultaneously with other signals

研究概览

简要总结

The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with cochlear implant(s).

The measures and strategies developed in this project could benefit all current and future cochlear implant wearers by improving their perception of the sound environment and their quality of life on a daily basis.

Researchers will compare normal hearing participant and participants with cochlear implant to describe the speech in noise and their perception of the sound environment.

Participants will perform audiological tests to assess their perception of the sound environment, with and without speech enhancement.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all participants:
  • 18 years of age or over,
  • Native French speaker,
  • Having given their consent to take part in the research.
  • For cochlear implant patients:
  • Adult implanted and declaring that they have been using the implant for at least 18 months,
  • Normal speech audiometry in silence
  • For controls reporting normal hearing:
  • Normal tonal audiometry (defined as a mean tonal loss not exceeding 30 decibel (dB) HL)
  • Normal speech audiometry in noise (SNR between -8 dB and -4dB inclusive)

排除标准

  • Be under guardianship or curatorship,
  • deprived of liberty by judicial or administrative decision, or subject to legal protection,
  • Non- native French speaker.

结局指标

主要结局

percentage of environmental sound cues correctly identified when presented simultaneously with other signals

时间窗: 2 years

次要结局

  • comparison of the percentages of correctly identified environmental sound cues obtained objectively and deduced from the signal-to-noise ratio corresponding to the trade-off indicated by the participant(2 years)
  • percentages of words correctly repeated by participants using personalised speech enhancement strategies(2 years)
  • comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off(2 years)
  • the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies(2 years)
  • comparison of percentages of words correctly repeated(2 years)
  • percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies(2 years)
  • percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies(2 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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