NCT06940726尚未招募不适用
Exploration Des Liens Entre Audition, Cognition et activité cérébrale Chez Des Personnes présentant un acouphène
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 主要终点
- Contingent negative variation (CNV) in EEG
研究概览
简要总结
The goal of this observational study is to understand the mechanisms underlying tinnitus, and improve the clinical assessment strategies needed to develop targeted therapeutic interventions by comparing endogenous attention capacities in healthy subjects and subjects with tinnitus
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
- •Age ≥ 18 years
- •Good written and oral comprehension of the French language
- •Normal or corrected vision
- •Group of people with tinnitus :
- •Chronic tinnitus > 3 months, uni or bilateral, stable (no period of remission)
- •Control group :
- •No tinnitus
排除标准
- •Presence of a known neurological disorder
- •Presence of a known degenerative pathology
- •Presence of a known hearing impairment
- •Presence of a motor disability of the upper limbs
- •Severe or profound deafness on one or both sides
- •Person under legal protection (guardianship, curatorship, etc.)
- •Use of hearing aids
研究组 & 干预措施
Healthy subjects
Sham Comparator
干预措施: Attention task (Behavioral)
Healthy subjects
Sham Comparator
干预措施: Quality of Life questionnaires (Other)
Healthy subjects
Sham Comparator
干预措施: Hearing tests (Other)
Healthy subjects
Sham Comparator
干预措施: Auditory prediction task (Behavioral)
Subjets with tinnitus
Experimental
干预措施: Quality of Life questionnaires (Other)
Subjets with tinnitus
Experimental
干预措施: Hearing tests (Other)
Subjets with tinnitus
Experimental
干预措施: Auditory prediction task (Behavioral)
Subjets with tinnitus
Experimental
干预措施: Attention task (Behavioral)
结局指标
主要结局
Contingent negative variation (CNV) in EEG
时间窗: 2 hours
次要结局
- Skin conductance (μS)(2 hours)
- Response reaction time (in ms)(2 hours)
- Answer accuracy (% correct answers)(2 hours)
- Cerebral oscillations (alpha bands) obtained by EEG during behavioural tasks(2 hours)
- Heart rate variability (in ms)(2 hours)
- Pupillometry (pupillary dilation in mm)(2 hours)
研究者
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