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Идёт набор NCT06691087

Sound Perception Study of Hearing-impaired People With Hearing Aids

Без фазы С лечением Auditory Perception

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Influence of the parameters of the sound timbre on the perception of a sound, Complex sound scene comprehension test, Complex sound scene comprehension test with hearing aids.
Кому может быть актуально
Состояния в реестре: Auditory Perception. Базовые параметры: 60 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое Influence of the parameters of the sound timbre on the perception of a sound
    The experiment consists of evaluating the sound level of n complex stimuli, then equalising them in loudness, in order to measure a loudness curve in function of timbre descriptors. The stimuli will then be listened to again in pairs. The task is there to compare the stimuli using a VAS to indicate how different the two sounds are.
  • Поведенческое Complex sound scene comprehension test
    The experiment consists in identifying the parameters of the sound timbre that most disturb the understanding of complex sound scenes, by asking the participants to identify sounds whose timbre has been modified.
  • Поведенческое Complex sound scene comprehension test with hearing aids
    The experiment will be identical to intervention 2. This time, the modification of the stimulus timbres will focus on the most problematic dimensional modifications, i.e. those where the difference between normal-hearing and hearing-impaired listeners is greatest. We will then modify the signal processing parameters of the hearing aid simulator (for example, the size of the averaging window or the gain balance of the filters), to observe their impact on the salience of certain stimuli.

Первичные конечные точки

  • Percentage of correct answers in melody comparison tasks in the hearing-impaired group compared with the normal-hearing group, [Срок оценки: 3-hours]
Вторичные конечные точки (3)
  • Characterisation of the dissimilarity between pairs of stimuli measured by a continuous perceptual scale [Срок оценки: 3-hours]
  • Evaluation of the perceived loudness level of a set of stimuli, measured using scales of magnitude. [Срок оценки: 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. [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • CeRIAH — Paris

Идентификаторы

NCT: NCT06691087 · 2024-040 · 2024-A01112-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗