NCT06921187尚未招募不适用
Etude de la Perception Auditive après Exposition PROgressive Aux Sons Aversifs Chez Des Personnes MISophonEs
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.).
排除标准
- •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.
结局指标
主要结局
score on a visual analogue scale from 0 (pleasant sound) to 10 (unpleasant sound)
时间窗: 1 week after enrollment
sounds will be presented at different decibels and the subject will be asked to rate the pleasantness/unpleasantness of the sound on a visual analogue scale
score on a visual analogue scale from 0 (very low intensity) to 10 (extremely intense)
时间窗: 1 week after enrollment
sounds will be presented at different decibels and the subject will be asked to rate the intensity of the sound on a visual analogue scale
次要结局
- Measuring the consistency of the psychoacoustic test(1 week after enrollement)
- the number of redundant themes in the semi-structured interviews(1 month after enrollment)
- score on a visual analogue scale from 0 (very little discomfort) to 10 (extreme discomfort)(1 month after enrollment and 2 months after enrollment)
研究者
研究点 (4)
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