Cognitive DysfunctionPACNCT06478888
Association Between Cognitive Impairment and the Presence of Hearing Problems and Precarious Conditions
An observational study of Cognitive Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Cognitive disorders are extremely common. Alzheimer's disease is the most common cognitive disorder, with an estimated 800,000 to 1 million patients suffering from this neurodegenerative disorder in France. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Dysfunction
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- May 2025to Nov 2027
- Phase
- Observational
- 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
Study population: Adult patients with cognitive problems associated with hearing impairment and/or precariousness
Who may be able to join
- Patient aged over 50
- Patient seen in our Memory unit for a cognitive complaint
- Patient with proven cognitive impairment (with or without hearing impairment) (MMSE ≤ 24)
- Patient not fitted with a hearing aid
- Patient with MMSE > 20 understands, reads and writes French well, if MMSE ≤ 20 needs to be accompanied by a relative.
Who cannot join
- Patient or relative refusing to take part in the study
- Absence of social security and AME
- Absence of cognitive disorders (MMSE>25)
- Cognitive disorder linked to a history of head trauma
- Patient under legal protection (guardianship, curatorship or safeguard of justice)
- Patients with a language barrier that may affect MMSE readings
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Cognitive disorders are extremely common. Alzheimer's disease is the most common cognitive disorder, with an estimated 800,000 to 1 million patients suffering from this neurodegenerative disorder in France. Cognitive disorders can also be observed in other common conditions such as Parkinson's disease and multiple sclerosis.
It has been shown that the presence of hearing impairment associated with cognitive disorders increases the latter. In addition, rare studies have shown that people in precarious situations are at greater risk of developing cognitive disorders early and rapidly, and consequently dementia.
The population of Seine Saint Denis (93) is known to be particularly affected by precariousness, which is why the investigators want to study its impact on patients with cognitive disorders associated with hearing impairment. These people need to be detected and supported in order to offer them a hearing aid that would improve or stabilize their cognitive state, or at least facilitate the rehabilitative management of their cognitive deficit.
Read the detailed description
The aim of our project is to study the association between the severity of cognitive problems and precariousness in people with hearing problems
While the data on the link between deafness and cognitive impairment is well established (Manrique et al., 2023), the data published in PubMed is poor or even non-existent when the precariousness of the individuals is taken into account.
In 2018, DREES published the results of the Capacités, Aides et REssources des seniors (CARE) ménages, seniors section survey, carried out in 2015 and looking at the living conditions and difficulties encountered in the daily lives of people aged 60 or over living at home. It was reported that 4% of the 15.7 million people over 60 in the French population had hearing difficulties, i.e. they reported having great difficulty or not managing at all to hear a conversation in a silent room. These difficulties differed according to whether the subjects surveyed were men or women, and also according to their social category. People with a degree (≥ bac +3) are 60% less likely to have hearing problems than those without a degree. These differences are linked in particular to inequalities in occupational risks, lifestyle habits and access to healthcare throughout the life cycle, making the link between precariousness and deafness. They also have an impact on immediate access to corrective measures. The most common cause of hearing loss in adults is presbycusis (physiological alteration of hearing function associated with aging), which can generally be compensated for by wearing a hearing aid. Of these people, seven out of ten do not wear a hearing aid.
the investigators would therefore like to study prospectively, in patients seen at our Memory unit and presenting with a cognitive impairment defined by an MMSE score ≤ 24 (140 patients/year), whether the presence of a precarious situation associated with a hearing impairment is an aggravating factor in this cognitive impairment.
- Conditions
- Cognitive Dysfunction
- Keywords
- cognitive disorders, hearing impairment, precariousness
- Medical subject headings
- Cognitive Dysfunction, Hearing Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE score in subjects with or without hearing problems who are not fitted with hearing aids and in those in precarious and non-precarious situations
to assess the association between the severity of cognitive impairment and the presence of precariousness and hearing impairment without hearing aids, in the population of Seine-Saint-Denis.
Measured: through study completion an average of 1 year
Secondary outcomes (6)
association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, as determined by neuropsychological tests with a hippocampal diagnostic orientation
to assess the association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, measured using neuropsychological tests other than the MMSE, in patients with cognitive disorders of hippocampal origin.
Measured: through study completion an average of 1 year
association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, as determined by neuropsychological tests with a frontal diagnostic orientation
to assess the association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, measured using neuropsychological tests other than the MMSE, in patients with cognitive disorders of frontal origin.
Measured: through study completion an average of 1 year
association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, as determined by neuropsychological tests with mixed hippocampal and frontal origin.
to assess the association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, measured using neuropsychological tests other than the MMSE,in patients with cognitive impairment of mixed hippocampal and frontal origin.
Measured: through study completion an average of 1 year
MMSE score in subjects with or without hearing problems who are not fitted with hearing aids and in those in precarious and non-precarious situations by distinguishing four groups of patients
to assess the association between the severity of cognitive impairment and the presence of precariousness and hearing impairment without hearing aids
Measured: through study completion an average of 1 year
Other neuropsychological tests to assess cognitive functions such as praxis and visual-spatial perception
To assess the association between precariousness, hearing problems without hearing aids and the severity of cognitive problems, measured using neuropsychological tests other than the MMSE, by distinguishing four groups of patients
Measured: through study completion an average of 1 year
Assess the quality of life of these patients
Quality of life assessed by the SF-36 questionnaire
Measured: through study completion an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study startMay 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478888
- Sponsor's protocol ID
- APHP240443
- Acronym
- PAC
- Status last verified
- May 2025
- First submitted
- 3 Jun 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cognitive Impairment and the Presence of Hearing Problems and Precarious Conditions
- ClinicalTrials.gov ID
- NCT06478888
- Acronym / sponsor ID
- PAC / APHP240443
- Conditions
- Cognitive Dysfunction
- Keywords
- cognitive disorders, hearing impairment, precariousness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Jun 2024 (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.
Cognitive disorders are extremely common. Alzheimer's disease is the most common cognitive disorder, with an estimated 800,000 to 1 million patients suffering from this neurodegenerative disorder in France. Cognitive disorders can also be observed in other common conditions such as Parkinson's disease and multiple sclerosis.
It has been shown that the presence of hearing impairment associated with cognitive disorders increases the latter. In addition, rare studies have shown that people in precarious situations are at greater risk of developing cognitive disorders early and rapidly, and consequently dementia.
The population of Seine Saint Denis (93) is known to be particularly affected by precariousness, which is why the investigators want to study its impact on patients with cognitive disorders associated with hearing impairment. These people need to be detected and supported in order to offer them a hearing aid that would improve or stabilize their cognitive state, or at least facilitate the rehabilitative management of their cognitive deficit.
Detailed description
The aim of our project is to study the association between the severity of cognitive problems and precariousness in people with hearing problems
While the data on the link between deafness and cognitive impairment is well established (Manrique et al., 2023), the data published in PubMed is poor or even non-existent when the precariousness of the individuals is taken into account.
In 2018, DREES published the results of the Capacités, Aides et REssources des seniors (CARE) ménages, seniors section survey, carried out in 2015 and looking at the living conditions and difficulties encountered in the daily lives of people aged 60 or over living at home. It was reported that 4% of the 15.7 million people over 60 in the French population had hearing difficulties, i.e. they reported having great difficulty or not managing at all to hear a conversation in a silent room. These difficulties differed according to whether the subjects surveyed were men or women, and also according to their social category. People with a degree (≥ bac +3) are 60% less likely to have hearing problems than those without a degree. These differences are linked in particular to inequalities in occupational risks, lifestyle habits and access to healthcare throughout the life cycle, making the link between precariousness and deafness. They also have an impact on immediate access to corrective measures. The most common cause of hearing loss in adults is presbycusis (physiological alteration of hearing function associated with aging), which can generally be compensated for by wearing a hearing aid. Of these people, seven out of ten do not wear a hearing aid.
the investigators would therefore like to study prospectively, in patients seen at our Memory unit and presenting with a cognitive impairment defined by an MMSE score ≤ 24 (140 patients/year), whether the presence of a precarious situation associated with a hearing impairment is an aggravating factor in this cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cognitive problems associated with hearing impairment and/or precariousness
Key inclusion criteria (5 listed)
- Patient aged over 50
- Patient seen in our Memory unit for a cognitive complaint
- Patient with proven cognitive impairment (with or without hearing impairment) (MMSE ≤ 24)
- Patient not fitted with a hearing aid
- Patient with MMSE > 20 understands, reads and writes French well, if MMSE ≤ 20 needs to be accompanied by a relative.
Key exclusion criteria (6 listed)
- Patient or relative refusing to take part in the study
- Absence of social security and AME
- Absence of cognitive disorders (MMSE>25)
- Cognitive disorder linked to a history of head trauma
- Patient under legal protection (guardianship, curatorship or safeguard of justice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMSE score in subjects with or without hearing problems who are not fitted with hearing aids and in those in precarious and non-precarious situations
Time frame: through study completion an average of 1 year
to assess the association between the severity of cognitive impairment and the presence of precariousness and hearing impairment without hearing aids, in the population of Seine-Saint-Denis.
6 secondary outcomes
association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, as determined by neuropsychological tests with a hippocampal diagnostic orientation
Time frame: through study completion an average of 1 year
association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, as determined by neuropsychological tests with a frontal diagnostic orientation
Time frame: through study completion an average of 1 year
association between the severity of cognitive disorders and the presence of precariousness and unaidable hearing disorders, as determined by neuropsychological tests with mixed hippocampal and frontal origin.
Time frame: through study completion an average of 1 year
MMSE score in subjects with or without hearing problems who are not fitted with hearing aids and in those in precarious and non-precarious situations by distinguishing four groups of patients
Time frame: through study completion an average of 1 year
Other neuropsychological tests to assess cognitive functions such as praxis and visual-spatial perception
Time frame: through study completion an average of 1 year
Assess the quality of life of these patients
Time frame: through study completion an average of 1 year
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 25 May 2025.
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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?
An observational study of Cognitive Dysfunction, run by Assistance Publique - Hôpitaux de Paris 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 5 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: opening soon, as of the sponsor's last update on 25 May 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 Arnaud LAPOSTOLLE, Dr (01 48 95 54 01, arnaud.lapostolle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE score in subjects with or without hearing problems who are not fitted with hearing aids and in those in precarious and non-precarious situations (time frame: through study completion an average of 1 year). 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 25 May 2025.