Deafness and Cognition in Middle-aged Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults

Conditions
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Mild Cognitive Impairment in Middle-aged Adults

Intervention / Treatment
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* Behavioral: Cognitive and audiometry evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases: Patients with severe to profound hearing loss<br>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 | Behavioral: Cognitive and audiometry evaluation<br>* For both Patients and controls: Cognitive functions evaluation Tonal and vocal audiometry Self questionnaires<br>|
| Active Comparator: Controls: 90 matched subjects with normal hearing<br>Healthy controls aged between 45 to 64 years with normal hearing on pure-tone audiometry (as function of ISO 7029 reference) | Behavioral: Cognitive and audiometry evaluation<br>* For both Patients and controls: Cognitive functions evaluation Tonal and vocal audiometry Self questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing | 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. | 1 day | 
| 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 | 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. | 1 day | 
| 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 | 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. | 1 day | 
| 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 | 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) | 1 day | 
| 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 | 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 | 1 day | 
| 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 | 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 | 1 day | 
| Evaluation of Cognitive Complaint Questionnaire to evaluate Cognitive assessment in patients with severe to profound hearing loss compare to subjects with normal hearing | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of MCI | Evaluate the type of MCI (amnesic, dysexecutive, multidomain) | 1 day | 
| Impact of the severity of the hearing loss on presence and severity of cognitive disorders | Subjective evaluation of hearing noise based on Speech and spatial questionnary : Patients have to mark a scale, for example with a cross, at the right place between 0 and 10. A mark on the value 10 means that he is perfectly capable of doing or experiencing what is described in the corresponding question. A mark on the 0 indicates that he/she is hardly able to do or experience what is described. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe and profound hearing loss, mild cognitive impairment (MCI), middle aged adult, depression