Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
ID06088953

Deafness Screening in a Memory Center for Subjects with Cognitive Disorders

Led by University Hospital, Lille · Updated on 2025-08-20

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Age-related hearing loss (ARHL) often develops gradually with age, similar to neurodegenerative diseases, and both conditions can be underdiagnosed because one may mask the other. The CogAudio project focuses on early detection of speech perception problems in noisy environments among patients with mild to moderate cognitive impairments using a specialized VRB test in a memory center setting. Participants undergo the VRB test at the start of the study to identify speech comprehension difficulties in noise. Regardless of the VRB test results, all participants are invited to complete a hearing test within three months, including tone audiometry and an ENT medical consultation, to confirm any hearing loss. The study aims to assess the VRB test's ability to detect deafness and explore the relationship between hearing loss, auditory discomfort, cognitive and functional changes, and brain activity markers over a 12-month period. During the study, participants and their caregivers provide information on hearing difficulties and cognitive status. Researchers will evaluate hearing ability using audiometry, assess cognitive and functional profiles, and measure brain responses related to sound discrimination. The main outcome is the VRB test's effectiveness at three months, with further assessments at 12 months to observe hearing aid use and changes in cognitive function. The study duration includes at least a 12-month follow-up to monitor these outcomes.

CONDITIONS

Brief Title

EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for the VRB test to detect speech comprehension disorders in noise.

Surveillance

Duration - 3 months

Participants are monitored to confirm the diagnosis of deafness through further hearing tests.

1 visit (in-person) for tone audiometry and ENT medical consultation within 3 months after screening.

Trial Site Locations

Total: 1 location

1

Hôpital Roger Salengro

Lille, France, 59037

Actively Recruiting

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Research Team

P

Pascaline Cassagnaud

J

Juliette Bochu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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