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临床试验/NCT06691087
NCT06691087尚未招募不适用

ÉTude de la pERception soNorE de Personnes maLentendantes équipées d'Aides Auditives

Institut Pasteur0 个研究点目标入组 75 人开始时间: 2025年3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
75
主要终点
Percentage of correct answers in melody comparison tasks in the hearing-impaired group compared with the normal-hearing group,

研究概览

简要总结

The aim of the ETERNEL project will be to study the influence of the perception of a single sound timbre on the understanding of a complex sound scene in hearing-impaired people with hearing aids. This will be done by quantifying the inability to manage a complex sound scene as a function of the timbre of the sounds making it up. The more a sound interferes with understanding the complex sound scene, the more salient that sound is considered to be. In this way, the investigators can determine which timbre dimensions make sounds particularly salient for the hearing impaired.

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
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all participants:
  • Age between 60 and 75
  • Native French speaker
  • Have given their consent to take part in the study.
  • Declare that they have an active social life or hobbies that stimulate their cognitive abilities
  • Have a MOCA score above 26
  • No tympano-ossicular dysfunction.
  • Voice in noise audiometry results showing normal results.
  • For participants with impaired hearing :
  • Pure tone audiometry showing audiograms of type N3 or N4 and symmetrical between the two ears.
  • Report having experienced problems with abnormally prominent sound.
  • For participants with normal hearing:
  • Pure tone audiometry showing audiograms with losses of less than 30 dBHl.

排除标准

  • Be under guardianship or curatorship,
  • Be deprived of liberty by judicial or administrative decision, or be under legal protection.
  • Bear the consequences of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis).

结局指标

主要结局

Percentage of correct answers in melody comparison tasks in the hearing-impaired group compared with the normal-hearing group,

时间窗: 3-hours

次要结局

  • Characterisation of the dissimilarity between pairs of stimuli measured by a continuous perceptual scale(3-hours)
  • Evaluation of the perceived loudness level of a set of stimuli, measured using scales of magnitude.(3-hours)
  • Comparison between the results of speech audiometry in noise, i.e number of words correctly repeated, with native settings versus settings minimising the discomfort of salient sounds for each participant with hearing loss.(up to 24 months)

研究者

申办方类型
Industry
责任方
Sponsor

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