EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity Hospital, Lille
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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...)
Trial design
Design model
Single group
Treatments tested in this trial
VRB test
Diagnostic testV1 (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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: perception disorder in noise in patients weakened by cognitive disorders.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 monthsSecondary outcomes
1
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)
Time frame
3 months or 12 months2
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.
Time frame
3 months or 12 months3
Frequency of patients with hearing aids at 12 months.
Frequency of patients with hearing aids at 12 months from inclusion
Time frame
3 months or 12 months4
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.
Time frame
3 months or 12 monthsSponsors and contacts
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Source ClinicalTrials.gov