Clinical trial NCT06478888: Association Between Cognitive Impairment and the Presence of Hearing Problems and Precarious Conditions
Official title: Association Between Cognitive Impairment and the Presence of Hearing Problems and Precarious Conditions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cognitive Dysfunction
Keywords: cognitive disorders
hearing impairment
precariousness
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 270
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with cognitive problems associated with hearing impairment and/or 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: through study completion an average of 1 year
Secondary outcomes:
measure: 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
timeFrame: through study completion an average of 1 year
measure: 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
timeFrame: through study completion an average of 1 year
measure: 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.
timeFrame: through study completion an average of 1 year
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 by distinguishing four groups of patients
timeFrame: through study completion an average of 1 year
measure: Other neuropsychological tests to assess cognitive functions such as praxis and visual-spatial perception
timeFrame: through study completion an average of 1 year
measure: Assess the quality of life of these patients
timeFrame: through study completion an average of 1 year
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Service de neurologie
Study officials:
References: