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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06478888
Acronym
PAC
Enrollment
270
Registered
2024-06-27
Start date
2025-05-31
Completion date
2027-11-30
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

Keywords

cognitive disorders, hearing impairment, precariousness

Brief 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. 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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MMSE score in subjects with or without hearing problems who are not fitted with hearing aids and in those in precarious and non-precarious situationsthrough study completion an average of 1 yearto 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.

Secondary

MeasureTime frameDescription
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 orientationthrough study completion an average of 1 yearto 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.
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.through study completion an average of 1 yearto 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.
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 orientationthrough study completion an average of 1 yearto 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.
Other neuropsychological tests to assess cognitive functions such as praxis and visual-spatial perceptionthrough study completion an average of 1 yearTo 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
Assess the quality of life of these patientsthrough study completion an average of 1 yearQuality of life assessed by the SF-36 questionnaire
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 patientsthrough study completion an average of 1 yearto assess the association between the severity of cognitive impairment and the presence of precariousness and hearing impairment without hearing aids

Countries

France

Contacts

Primary ContactArnaud LAPOSTOLLE, Dr
arnaud.lapostolle@aphp.fr01 48 95 54 01
Backup ContactBertrand Degos
bertrand.degos@aphp.fr01 48 95 54 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026