EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER

Study Overview
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Brief Summary
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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.

Official Title
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DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS

Conditions
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Cognitive Disorder, Deafness

Intervention / Treatment
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* Diagnostic Test: VRB test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: perception disorder in noise in patients weakened by cognitive disorders.<br>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. | Diagnostic Test: VRB test<br>* V1 (inclusion) : VRB test for detecting speech comprehension disorders in noise. V2 (3 months) : all patients ( independent of the result of the VRB test) will be invited to attend a hearing test within 3 months in order to confirm the diagnosis of deafness by means of a tone audiometry and an ENT medical consultation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment. | Area under the ROC (receiver operating characteristic) curve of the VRB test for hearing loss screening. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Sensitivity, specificity, negative and positive predictive values of the pathological threshold defined in the general population (>3 BSR ) for hearing loss screening (as defined in the primary endpoint) | 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 | Hearing loss is defined by the VRB test score. The auditory complaint expressed by the patient is defined by the score on the HHIE-S questionnaire completed by the patient himself; the auditory complaint noted by the entourage is defined by the score on the adapted HHIE-S questionnaire completed by the caregiver present at the consultation at M0. | 3 months or 12 months | 
| Frequency of patients with hearing aids at 12 months. | Frequency of patients with hearing aids at 12 months from inclusion | 3 months or 12 months | 
| Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. | Variation in scores between M0 and M12 on HAD neuropsychological and speech therapy test. | 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 | Amplitude and latency of the P300 wave; Tone audiometry score 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. | Variation in scores between M0 and M12 on WHOQOL-BREF neuropsychological test | 3 months or 12 months | 
| Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. | Variation in scores between M0 and M12 on QFS functional scale | 3 months or 12 months | 
| Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. | Variation in scores between M0 and M12 on LARS neuropsychological test. | 3 months or 12 months | 
| Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. | Variation in scores between M0 and M12 on EQ-5D-3L neuropsychological test. | 3 months or 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Disorder, Deafness