Study of Auditory Perception After Progressive Exposure to Aversive Sounds in People With Misophonia

Официальное название

Etude de la Perception Auditive après Exposition PROgressive Aux Sons Aversifs Chez Des Personnes MISophonEs

Обзор

The primary objective of the project is to characterise and measure the auditory perception of subjects with misophonia compared with the auditory perception of control subjects.

Вмешательства

• Поведенческое Psychoacoustic test
  Natural sounds will be presented at different decibels (dB), and the subject will be asked to rate the pleasantness/unpleasantness of the sound heard on a visual analogue scale, as well as the loudness (subjective intensity) of the sound heard.
• Другое semi-structured interviews
  interview, designed under the supervision of a psychologist and using the methodology of micro-phenomenological interviews the aim of these interviews is to gain access to the participants' experiences, as they describe them in the first person, during misophonic episodes
• Другое Exposure to unpleasant sounds
  Home exposure is a practice whereby participants voluntarily subject themselves to SMs in a controlled environment. Participants will be asked to complete two tasks: firstly, they will have to expose themselves to all 10 sounds at least twice a week; secondly, they will have to record the annoyance felt for each sound and the subjective loudness (loudness) of each SM using VAS.

Первичные конечные точки

• score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound) [Срок оценки: 1 week after enrollment]
• score on a visual analogue scale from 0 (very low intensity) to 10 (extremely intense) [Срок оценки: 1 week after enrollment]

Вторичные конечные точки (3)

• Measuring the consistency of the psychoacoustic test [Срок оценки: 1 week after enrollement]
• the number of redundant themes in the semi-structured interviews [Срок оценки: 1 month after enrollment]
• score on a visual analogue scale from 0 (very little discomfort) to 10 (extreme discomfort) [Срок оценки: 1 month after enrollment and 2 months after enrollment]

Критерии участия

Критерии включения

For all participants

• Obtain oral consent from the participant after receiving information about the study,
• Be 18 years or older on the day of inclusion,
• Be fluent in French (spoken and written),
• Have no known hearing loss, verified by pure tone audiometry.
• Declare that they do not have tinnitus,
• Declare that they do not have hyperacusis, verified by measuring discomfort thresholds.
• Be affiliated to the social security or equivalent scheme.

For participants with misophonia:

\- Declare discomfort, reduced tolerance to specific sounds (mouth noises, throat clearing, breathing, etc.).

Критерии исключения

• Bear the after-effects 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),
• 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

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 2 центра

• Centre de Recherche en Psychologie et Neuroscience (CRPN) — Marseille
• CEntre de Recherche et d'Innovation en Audiologie Humaine — Paris

Идентификаторы

NCT: NCT06921187 · 2024-058 · 2024-A02048-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗