Association Between Cognitive Impairment and the Presence of Hearing Problems and Precarious Conditions

NCT ID: NCT06478888

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-31

Study Completion Date

2027-11-30

Brief Summary

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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

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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

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Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de neurologie

Bobigny, , France

Site Status

Countries

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France

Central Contacts

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Arnaud LAPOSTOLLE, Dr

Role: CONTACT

01 48 95 54 01

Bertrand Degos

Role: CONTACT

01 48 95 54 00

Facility Contacts

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Arnaud LAPOSTOLLE

Role: primary

Other Identifiers

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APHP240443

Identifier Type: -

Identifier Source: org_study_id

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