MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

Обзор

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.

Вмешательства

• Поведенческое Speech in noise comprehension test
  Speech in noise comprehension tests consisting of listening to a speech source and one or more competing sources (noise, speech or sound cues) simultaneously. The volunteers will have to repeat the speech source in order to assess intelligibility for each situation, as a function of the intensity ratio of the two sources (SNR).
• Поведенческое Objective tests of perception of ambient sound cues in noise
  Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. The volunteers will have to identify sound cues in order to assess the ability to perceive the sound environment for each situation, depending on the intensity ratio of the different sources.
• Поведенческое Subjective tests of perception of ambient sound cues in noise
  Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. Using a simple interface, the volunteers will have to identify the intensity ratio of the sources that they consider to be the best compromise between understanding speech and perceiving the sound environment.

Первичные конечные точки

• percentage of environmental sound cues correctly identified when presented simultaneously with other signals [Срок оценки: 2 years]

Вторичные конечные точки (7)

• 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 [Срок оценки: 2 years]
• the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies [Срок оценки: 2 years]
• percentages of words correctly repeated by participants using personalised speech enhancement strategies [Срок оценки: 2 years]
• comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off [Срок оценки: 2 years]
• percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies [Срок оценки: 2 years]
• percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies [Срок оценки: 2 years]
• comparison of percentages of words correctly repeated [Срок оценки: 2 years]

Критерии участия

Критерии включения

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)

Критерии исключения

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

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

• CEntre de Recherche et d'Innovation en Audiologie Humaine — Paris

Идентификаторы

NCT: NCT06420921 · 2023-153

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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