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EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER (CogAudio)

Primary Purpose

Cognitive Disorder, Deafness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VRB test
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cognitive Disorder focused on measuring Cognitive Disorder, Deafness

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    perception disorder in noise in patients weakened by cognitive disorders.

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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)
    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.
    Frequency of patients with hearing aids at 12 months.
    Frequency 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.
    Variation 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 silence
    Amplitude and latency of the P300 wave; Tone audiometry score in silence.
    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
    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
    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.
    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.

    Full Information

    First Posted
    August 21, 2023
    Last Updated
    October 12, 2023
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06088953
    Brief Title
    EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER
    Acronym
    CogAudio
    Official Title
    DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Disorder, Deafness
    Keywords
    Cognitive Disorder, Deafness

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    perception disorder in noise in patients weakened by cognitive disorders.
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    VRB test
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment.
    Description
    Area under the ROC (receiver operating characteristic) curve of the VRB test for hearing loss screening.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    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
    Title
    correlation between the hearing loss and the auditory discomfort (complaint) expressed by the patient and that observed by the caregiver
    Description
    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
    Title
    Frequency of patients with hearing aids at 12 months.
    Description
    Frequency of patients with hearing aids at 12 months from inclusion
    Time Frame
    3 months or 12 months
    Title
    Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
    Description
    Variation in scores between M0 and M12 on HAD neuropsychological and speech therapy test.
    Time Frame
    3 months or 12 months
    Title
    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
    Description
    Amplitude and latency of the P300 wave; Tone audiometry score in silence.
    Time Frame
    3 months or 12 months
    Title
    Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
    Description
    Variation in scores between M0 and M12 on WHOQOL-BREF neuropsychological test
    Time Frame
    3 months or 12 months
    Title
    Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
    Description
    Variation in scores between M0 and M12 on QFS functional scale
    Time Frame
    3 months or 12 months
    Title
    Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
    Description
    Variation in scores between M0 and M12 on LARS neuropsychological test.
    Time Frame
    3 months or 12 months
    Title
    Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
    Description
    Variation in scores between M0 and M12 on EQ-5D-3L neuropsychological test.
    Time Frame
    3 months or 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER

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