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EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER

DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06088953
Acronym
CogAudio
Enrollment
200
Registered
2023-10-18
Start date
2025-05-27
Completion date
2027-08-27
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Disorder, Deafness

Keywords

Cognitive Disorder, Deafness

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.

Interventions

DIAGNOSTIC_TESTVRB 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.

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
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 monthsSensitivity, 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 caregiver3 months or 12 monthsHearing 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 monthsFrequency 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 monthsVariation 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 silence3 months or 12 monthsAmplitude and latency of the P300 wave; Tone audiometry score in silence.

Countries

France

Contacts

Primary ContactPascaline Cassagnaud
Pascaline.CASSAGNAUD@chu-lille.fr03.20.44 60 21
Backup ContactJuliette Bochu
juliette.bochu@chu-lille.fr0320444145

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026