Cognitive DisorderCogAudioNCT06088953
EARLY DETECTION OF DEAFNESS IN A MEMORY CENTER
A study testing VRB test in people with Cognitive Disorder and Deafness, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Disorder, Deafness
- What is being tested?
- VRB test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2025to 27 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Roger Salengro
Lille, 59037
Pascaline Cassagnaud
About this study
Official title: 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.
- Conditions
- Cognitive Disorder, Deafness
- Being tested
- VRB test
- Keywords
- Cognitive Disorder, Deafness
- Medical subject headings
- Cognitive Dysfunction, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: VRB test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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)
Measured: 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
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.
Measured: 3 months or 12 months
Frequency of patients with hearing aids at 12 months.
Frequency of patients with hearing aids at 12 months from inclusion
Measured: 3 months or 12 months
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.
Measured: 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
Amplitude and latency of the P300 wave; Tone audiometry score in silence.
Measured: 3 months or 12 months
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
Measured: 3 months or 12 months
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
Measured: 3 months or 12 months
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.
Measured: 3 months or 12 months
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.
Measured: 3 months or 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start27 May 2025
- Primary completion27 Aug 2026 (estimated)
- Study completion27 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088953
- Sponsor's protocol ID
- 2022_0392
- Acronym
- CogAudio
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEAFNESS SCREENING IN A MEMORY CENTER IN SUBJECTS WITH COGNITIVE DISORDERS
- ClinicalTrials.gov ID
- NCT06088953
- Acronym / sponsor ID
- CogAudio / 2022_0392
- Conditions
- Cognitive Disorder, Deafness
- Keywords
- Cognitive Disorder, Deafness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 27 Aug 2026 (estimated)
- Study completion
- 27 Aug 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| perception disorder in noise in patients weakened by cognitive disorders. | Experimental | Diagnostic Test: VRB testThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRB testV1 (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. | Diagnostic test | perception disorder in noise in patients weakened by cognitive disorders. |
Primary outcome
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.
9 secondary outcomes
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
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
Frequency of patients with hearing aids at 12 months.
Time frame: 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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRB test in people with Cognitive Disorder and Deafness, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascaline Cassagnaud (03.20.44 60 21, Pascaline.CASSAGNAUD@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the VRB test to detect deafness in patients over 50 with mild to moderate cognitive impairment. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.