EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER (CogAudio)

August 19, 2025 updated by: University Hospital, Lille

DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • Hopital Roger Salengro
        • Contact:
          • Pascaline Cassagnaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: perception disorder in noise in patients weakened by cognitive disorders.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment.
Time Frame: 3 months
Area under the ROC (receiver operating characteristic) curve of the VRB test for hearing loss screening.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 months or 12 months
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
correlation between the hearing loss and the auditory discomfort (complaint) expressed by the patient and that observed by the caregiver
Time Frame: 3 months or 12 months
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
Frequency of patients with hearing aids at 12 months.
Time Frame: 3 months or 12 months
Frequency of patients with hearing aids at 12 months from inclusion
3 months or 12 months
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
Time Frame: 3 months or 12 months
Variation in scores between M0 and M12 on HAD neuropsychological and speech therapy test.
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
Time Frame: 3 months or 12 months
Amplitude and latency of the P300 wave; Tone audiometry score in silence.
3 months or 12 months
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
Time Frame: 3 months or 12 months
Variation in scores between M0 and M12 on WHOQOL-BREF neuropsychological test
3 months or 12 months
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
Time Frame: 3 months or 12 months
Variation in scores between M0 and M12 on QFS functional scale
3 months or 12 months
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
Time Frame: 3 months or 12 months
Variation in scores between M0 and M12 on LARS neuropsychological test.
3 months or 12 months
Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.
Time Frame: 3 months or 12 months
Variation in scores between M0 and M12 on EQ-5D-3L neuropsychological test.
3 months or 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

August 27, 2026

Study Completion (Estimated)

August 27, 2027

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_0392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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