Clinical trial NCT06088953: EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER
Official title: DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Disorder
Deafness
Keywords: Cognitive Disorder
Deafness
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment.
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months or 12 months
measure: correlation between the hearing loss and the auditory discomfort (complaint) expressed by the patient and that observed by the caregiver
timeFrame: 3 months or 12 months
measure: Frequency of patients with hearing aids at 12 months.
timeFrame: 3 months or 12 months
measure: Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
timeFrame: 3 months or 12 months
measure: 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
timeFrame: 3 months or 12 months
measure: Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
timeFrame: 3 months or 12 months
measure: Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
timeFrame: 3 months or 12 months
measure: Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
timeFrame: 3 months or 12 months
measure: Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
timeFrame: 3 months or 12 months
Other outcomes:
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