NCT06088953招募中不适用
DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年5月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment.
研究概览
简要总结
Age-related hearing loss (ARHL), like neurodegenerative diseases, appears insidiously with age. As major public health issues, they are nonetheless under-diagnosed because the presence of one can hinder the objectification of the other.
The CogAudio project aims to detect early and in an ambulatory mode in a memory centre a speech perception disorder in noise thanks to the VRB test in patients weakened by cognitive disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with mild to moderate cognitive impairment, with an MMSE score ≥15/30
- •Patient mastering the French language
- •Patient who has given written consent to participate in the trial
- •Socially insured patient
- •Patient willing to comply with all study procedures and duration
- •Patient accompanied by a study partner
排除标准
- •Medical history of diagnosed deafness, fitted or not
- •History of progressive otological pathology or presence of tympanic obstruction (>1/3 of the surface of the eardrum)
- •History of unstabilized psychiatric pathology
- •Major visual impairment (Age-Related Macular Degeneration AMD...)
- •Established diagnosis of major language disorders (Primary Progressive Aphasia APP...)
- •Major under legal protection measure
结局指标
主要结局
Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment.
时间窗: 3 months
Area under the ROC (receiver operating characteristic) curve of the VRB test for hearing loss screening.
次要结局
- Frequency of patients with hearing aids at 12 months.(3 months or 12 months)
- correlation between the hearing loss and the auditory discomfort (complaint) expressed by the patient and that observed by the caregiver(3 months or 12 months)
- To assess the diagnostic values of the VRB threshold associated with a disorder of speech comprehension in noise defined in the general population to screen for deafness in patients over 50 years of age with mild to moderate cognitive impairment.(3 months or 12 months)
- To assess the correlation between an objective cortical marker of selective attention (long latency evoked potentials: P300 wave amplitude; patients' ability to discriminate sounds in silence), and subjects' performance in tone audiometry in silence(3 months or 12 months)
- Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.(3 months or 12 months)
研究者
研究点 (2)
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