NCT06088953

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
May 2025Aug 2027

First Submitted

Initial submission to the registry

August 21, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 27, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2027

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

August 21, 2023

Last Update Submit

August 19, 2025

Conditions

Cognitive DisorderDeafness

Keywords

Cognitive DisorderDeafness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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.

    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

    3 months or 12 months

  • Frequency of patients with hearing aids at 12 months.

    3 months or 12 months

  • Evolution of the cognitive and functional profile at 12 months between patients with deafness and patients without deafness.

    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

    3 months or 12 months

  • +4 more secondary outcomes

Study Arms (1)

perception disorder in noise in patients weakened by cognitive disorders.

EXPERIMENTAL

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

Interventions

VRB testDIAGNOSTIC_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.

perception disorder in noise in patients weakened by cognitive disorders.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionDeafness

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Pascaline Cassagnaud

CONTACT

03.20.44 60 21Pascaline.CASSAGNAUD@chu-lille.fr

Juliette Bochu

CONTACT

0320444145juliette.bochu@chu-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

October 18, 2023

Study Start

May 27, 2025

Primary Completion (Estimated)

August 27, 2026

Study Completion (Estimated)

August 27, 2027

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)