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Идёт набор NCT05468567

Three-dimensional Perception of Sounds in Military with Acoustic Trauma

Наблюдательное Hearing Loss

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: SPHERE protocol : Spatial hearing performances test, French Matrix Test : audiology test of speech in noise perception, SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale).
Кому может быть актуально
Состояния в реестре: Hearing Loss. Базовые параметры: 18 лет — 65 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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Обзор

Spatial hearing capacities of soldiers with acoustic trauma are evaluated in ENT consultations with routine tests (i.e. tonal audiometry, voice audiometry). While the results conclude that soldiers with acoustic trauma have sufficient abilities to carry out professional missions, soldiers report recurring complaints of sound localization (spatial hearing), i.e. difficulties in identifying the position of sound sources in their environment. However, there is currently no objective test to identify and objectify these complaints of spatial hearing. The investigators have developed a new approach (SPHERE) based on virtual reality and 3D motion tracking, allowing us to evaluate and record the spatial hearing performance of subject with hearing deficit. This system allowed us to highlight localization deficits in three-dimensional space. This project explores and quantifies the spatial hearing impairments of soldiers with acoustic trauma. The quantification of the spatial hearing capacities will allow to define a specific rehabilitation strategy of spatial hearing deficits.

Вмешательства

  • Диагностический тест SPHERE protocol : Spatial hearing performances test
    Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHEAR protocol).
  • Диагностический тест French Matrix Test : audiology test of speech in noise perception
    Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.
  • Поведенческое SSQ15 questionnaire of life : (The Speech, Spatial and Other Qualities of Hearing Scale)
    The SSQ questionnaire is a clinical subjective scale that allows evaluating of hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten.

Первичные конечные точки

  • Cumulative error value "3d-D" measuring the spatial hearing performances [Срок оценки: at Day 1 during the inclusion visit. The test last 30 minutes.]
Вторичные конечные точки (2)
  • Correlation between the score obtained in the SSQ and the 3dD auditory spatialization performance. [Срок оценки: at Day 1 during the inclusion visit.]
  • Correlation between the score obtained in the Framatrix and the 3dD auditory spatialization performance. [Срок оценки: at Day 1 during the inclusion visit.]

Критерии участия

Критерии включения

acoustic traumatized military group :

  • Age between 18 and 65 inclusive
  • Active or reserve military personnel
  • Diagnosis of noise trauma for at least one month
  • Regularly followed up in the ENT department of the Desgenettes Army Training Hospital in Lyon or in the medical offices of the Army Medical Centers.
  • Able to understand the experimental instructions
  • Affiliated to a social security scheme
  • Having been informed of the study and having given their agreement to participate normal hearing group :
  • Age between 18 and 65 years inclusive
  • Able to understand the experimental instructions
  • Affiliated to a social security scheme
  • Having been informed of the study and given their agreement to participate

Критерии исключения

  • Known current or past neurological or psychiatric disorder
  • Oculomotor/visual disorder
  • Bilateral vestibular areflexia
  • Person under court protection, guardianship or curatorship
  • Pregnant or breastfeeding woman
  • Known hearing loss for normal hearing group

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Франция · 1 центр
  • Hopital Edouard Herriot — Lyon

Идентификаторы

NCT: NCT05468567 · 69HCL21_0692

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗