Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Evaluation of Trail making tests (TMT) A et B to evaluate executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing
研究概览
简要总结
A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years. The aim of our study was to compare cognitive function between patients with severe and profound hearing loss and patients with normal hearing in patients aged 45 to 64 years.
详细描述
This case-control study will include 180 middle aged adults (90 cases, 90 healthy controls) matched on sex, age, education level in order to find an association between severe and profound hearing loss and presence of mild cognitive impairment.
90 subjects with severe to profound hearing loss,, with a maximum speech intelligibility of 70% for Fournier's disyllabic words in silence with properly fitted hearing aids could be included. Cognition evaluated on a battery of 5 tests, depression and dependance will be compared to healthy controls with normal hearing on pure-tone audiometry (as function of ISO 7029 reference) The subjects (cases and controls) will be recruited in the ENT consultation from the Cochlear Implant Center (Unité fonctionnelle implants auditifs, Pitié-Salpêtrière Hospital, Head: Dr Isabelle Mosnier)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cases: Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL, current in french
- •Controls: normal hearing subjects matched on age, sex and education level
排除标准
- •Associated disability that prevents the tests from being performed
- •Past and current history of neurological and psychiatric disorders including meningitis
- •Psychotropic drug treatment
- •Vulnerable subject
结局指标
主要结局
Evaluation of Trail making tests (TMT) A et B to evaluate executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing
时间窗: 1 day
Trail making tests (TMT) A et B: rapidity test to evaluate executive functions. Score is expressed correct displacement number (in A and B parts) divided by time and multiply by ten.
Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing
时间窗: 1 day
test to assess cognitive impairment. Result of this test is expressed on 30 points and is analyzed in function of age, sex, education level depending on publicised norms.
Evaluation of "Fluences verbales sémantique et phonémique" to evaluate linguistic skills in patients with severe to profound hearing loss compare to subjects with normal hearing
时间窗: 1 day
"Fluences verbales sémantique et phonémique": test to evaluate linguistic skills. Score correspond to the number of words cited in 60 minutes in a specific category.
Evaluation of 16-item Free and Cue Selective Recall Test (RLRI/16) to evaluate episodic memory in patients with severe to profound hearing loss compare to subjects with normal hearing
时间窗: 1 day
16-item Free and Cue Selective Recall Test (RLRI/16): test adapted in French from the Free and Cue Selective Reminding test (FCSRT) assessing episodic memory. After an encoding phase during which the subject reads and memorizes 16 words 4 by 4, the subject is asked to freely recall as many words as possible in 2 minutes, cues are then provided. The free and cue recall is repeated 3 times and then 20 minutes later (delayed recall). The score used in the study will be: sum of the immediate free recall of the first three trials (0 to 48) and score of the delayed free recall (0 to 16)
Evaluation of Digit Symbol Substitution Test to evaluate psychomotor speed and executive functions, executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing
时间窗: 1 day
Digit Symbol Substitution Test (DSST) of the Weschsler Adult Intelligence Scale-IV (WAIS-IV): test assessing attention, psychomotor speed and executive functions, executive functions. This test presents a matrix of nine digit-symbol pairs on a sheet of paper. A list of 135 numbers is presented in random order. The subject must associate the symbol corresponding to the number as quickly as possible by following the matrix. The score used will be: number of correctly associated symbols in 90 seconds
Evaluation of Instrumental activities of daily living scale to evaluate the level of dependence of dependence of the subjects in patients with severe to profound hearing loss compare to subjects with normal hearing
时间窗: 1 day
Instrumental activities of daily living scale (IADL): evaluation of the level of dependence of dependence of the subjects \[45\] (addendum 2). Patients with MCI must remain independent. The existence of dependence contributes to the diagnosis of of dementia
Evaluation of Cognitive Complaint Questionnaire to evaluate Cognitive assessment in patients with severe to profound hearing loss compare to subjects with normal hearing
时间窗: 1 day
Assessment or monitoring to be instituted for a score of 3 or more, and/or one "yes" answer to question 5, and/or two "yes" answers to questions: A,4,5,7,8.
次要结局
- Type of MCI(1 day)
- Impact of the severity of the hearing loss on presence and severity of cognitive disorders(1 day)