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NCT Number: NCT06088953

EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER

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.

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Key information

Conditions

Cognitive Disorder Cognition Disorders Cognitive Dysfunction Deafness Ear Diseases Hearing Disorders Hearing Loss Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro

Lille, 59037, France

Location status: Recruiting

Location contact

Pascaline Cassagnaud

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VRB test

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juliette Bochu

CONTACT

[email protected]

0320444145

Pascaline Cassagnaud

CONTACT

[email protected]

03.20.44 60 21

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS

Acronym: CogAudio

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2023
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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