CogAudio: EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06088953

Collaborator

(none)

200

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Disorder Deafness	Diagnostic Test: VRB test	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS

Anticipated Study Start Date :

Oct 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: perception disorder in noise in patients weakened by cognitive disorders. 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 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.

Arm

Intervention/Treatment

Experimental: perception disorder in noise in patients weakened by cognitive disorders.

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

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.

Outcome Measures

Primary Outcome Measures

Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment. [3 months]
Area under the ROC (receiver operating characteristic) curve of the VRB test for hearing loss screening.

Secondary Outcome Measures

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]
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)
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]
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.
Frequency of patients with hearing aids at 12 months. [3 months or 12 months]
Frequency of patients with hearing aids at 12 months from inclusion
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. [3 months or 12 months]
Variation in scores between M0 and M12 on HAD neuropsychological and speech therapy test.
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]
Amplitude and latency of the P300 wave; Tone audiometry score in silence.
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. [3 months or 12 months]
Variation in scores between M0 and M12 on WHOQOL-BREF neuropsychological test
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. [3 months or 12 months]
Variation in scores between M0 and M12 on QFS functional scale
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. [3 months or 12 months]
Variation in scores between M0 and M12 on LARS neuropsychological test.
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness. [3 months or 12 months]
Variation in scores between M0 and M12 on EQ-5D-3L neuropsychological test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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