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Идёт набор NCT06264245

Users of Remote Conferencing and Compression of Sound Dynamics : Auditory Effects

Наблюдательное 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: Audiological profile, Hearing self-assessments, Objective and subjective audiological tests, Self-assessment of exposure sound quality.
Кому может быть актуально
Состояния в реестре: Auditory Perception. Базовые параметры: от 18 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
Бельгия, Франция
Следующий шаг
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Обзор

The COMPRESSED project is a descriptive, bi-centric and non-invasive study carried out by the CERIAH - IDA - Institut Pasteur and the Haute École Léonard de Vinci in Brussels on volunteer participants identified in two groups : * be subject to high exposure to compressed sound, as defined by professional participation in events on broadcast platforms using sound signal processing systems, over the last 3 years, * be subject to moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student following certain distance learning courses. on a videoconferencing platform, alternating with other face-to-face courses, with the ability to listen during breaks, which have been taught for a maximum of 2 years. The main objective of the COMPRESSED study is to evaluate the auditory effects of exposure to manipulated sounds (compression, filtering, equalisation, accentuation, etc.) from sound distribution platforms on the auditory system of participants who are regularly exposed to these sounds as a result of their professional activity.

Вмешательства

  • Другое Audiological profile
    Video otoscopy Tympanometry High-frequency tonal audiometry
  • Другое Hearing self-assessments
    Hearing skills questionnaire Subjective assessment of tinnitus using a visual analogue scale Self-questionnaire on the impact of tinnitus Hyperacusis self-questionnaire
  • Другое Objective and subjective audiological tests
    Acoustic Omission Measurement of the stapedial reflex by tympanometry High-frequency tonal audiometry - exposed ear only Speech audiometry in noise Tinnitus and subjective discomfort thresholds Psychoacoustic intensity perception test
  • Другое Self-assessment of exposure sound quality
    A self-assessment of the sound quality of the manipulated sounds heard during the exhibition will be carried out during the second follow-up visit. The elements on which the participant will be asked to make a qualitative judgement will relate to intelligibility difficulties or not; background noise (these two items in the form of a mark between 0 and 10); the clear, muffled or shrill nature of the sounds, their resonant or saturated side.

Первичные конечные точки

  • Hearing assessments of participants exposed to manipulated sounds after and before exposure [Срок оценки: 2 weeks]
Вторичные конечные точки (5)
  • Audiometric thresholds in pure tone from 125 to 8000 Hz in the subject's exposed ear before and approximately one hour after exposure, [Срок оценки: 2 weeks]
  • Difference between the threshold of the protective reflex of the auditory pathways (middle ear muscles) measured by impedancemetry in the exposed ear when a contralateral noise is presented for a few seconds. [Срок оценки: 2 weeks]
  • Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli [Срок оценки: 2 weeks]
  • Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure. [Срок оценки: 2 weeks]
  • Effectiveness of the protective auditory reflexes (or acoustic reflexes), obtained by impedancemetry and derived from the reading of the otoemissions for each participant. [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

For all participants:

  • Age 18 or over,
  • Work with platforms using sound signal processing systems,
  • Fluent in English,
  • Fluent in French,
  • Declare that they have no hearing loss.

For participants in the high exposure group:

\- Have had a professional activity over the last three years using broadcasting platforms with sound signal processing systems,

For participants in the moderate or limited exposure group:

\- Have worked between one semester and two years with platforms using sound signal processing systems.

Критерии исключения

  • Conductive or mixed hearing loss, i.e. where the hearing loss affects both the outer and/or middle ear and the inner ear.
  • Have an asymmetric hearing loss, i.e. a difference in average hearing loss between the left and right ear of more than 20 dB,
  • Have a history of otitis and/or an ENT disease that permanently affects hearing (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis),
  • Not fluent in English
  • Be under guardianship,
  • Deprived of liberty by judicial or administrative decision, or subject to legal protection.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 1 центр
  • Haute Ecole Léonard De Vinci — Brussels
Франция · 1 центр
  • CEntre de Recherche et d'Innovation en Audiologie Humaine — Paris

Идентификаторы

NCT: NCT06264245 · 2022-126 · 2023-A00985-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗