EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER

Deafness Clinical Trial

— CogAudio  

Official title:

DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088953
• Other study ID #: 2022_0392
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorder
• Cognitive Dysfunction
• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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)	3 months or 12 months
Secondary	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.	3 months or 12 months
Secondary	Frequency of patients with hearing aids at 12 months.	Frequency of patients with hearing aids at 12 months from inclusion	3 months or 12 months
Secondary	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.	3 months or 12 months
Secondary	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.	3 months or 12 months
Secondary	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	3 months or 12 months
Secondary	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	3 months or 12 months
Secondary	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.	3 months or 12 months
Secondary	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.	3 months or 12 months