DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS

University Hospital, Lille1 site in 1 country200 target enrollmentMay 27, 2025

ConditionsCognitive Disorder Deafness

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cognitive Disorder
Sponsor: University Hospital, Lille
Enrollment: 200
Locations: 1
Primary Endpoint: Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment.
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 27, 2025

End Date

August 27, 2027

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment.

Time Frame: 3 months

Area under the ROC (receiver operating characteristic) curve of the VRB test for hearing loss screening.

Secondary Outcomes

Frequency of patients with hearing aids at 12 months.(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(3 months or 12 months)
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.(3 months or 12 months)
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)
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)