An interventional study of VRB test in Cognitive Disorder and Deafness, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Screening
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 200 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 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.
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 months
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 months
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 months
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 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
Amplitude and latency of the P300 wave; Tone audiometry score in silence.
Time frame: 3 months or 12 months
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 WHOQOL-BREF neuropsychological test
Time frame: 3 months or 12 months
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 QFS functional scale
Time frame: 3 months or 12 months
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 LARS neuropsychological test.
Time frame: 3 months or 12 months
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 EQ-5D-3L neuropsychological test.
Time frame: 3 months or 12 months
Plan to share: No
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