Impact on Cognitive Impairment of Hearing Disorders Associated or Not With Precarious Conditions

Not yet recruiting

• Conditions: Cognitive Dysfunction

• Registration Number: NCT06478888
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Our project aims to study the effect of precariousness on cognitive disorders in people with hearing impairments.

While data on the link between deafness and cognitive disorders are well established, the data published in PubMed are poor or even non-existent when the precariousness of 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 Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27
• Study Start: 2024-09
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Patient aged over 18
• 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 who understands, reads and writes French well

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Exclusion Criteria

• Patient refusing to take part in the study
• No social security or AME entitlement
• No cognitive disorders (MMSE>25)
• Patient under legal protection (guardianship, curatorship or safeguard of justice)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the MMSE score in subjects with unaidided hearing impairment, comparing precarious	through study completion an average of 1 year	to determine the effect of precariousness on cognitive impairment, as defined by MMSE score, in subjects with unaid hearing impairment.

Secondary Outcome Measures

Name	Time	Method
impact of precariousness and unaidable hearing impairment on cognitive impairment as determined by other neuropsychological tests (other than the MMSE score)	through study completion an average of 1 year	To evaluate and compare: Other neuropsychological tests
Evaluate the quality of life of these patients.	through study completion an average of 1 year	To evaluate and compare : Quality of life assessed by SF-36 questionnaire
impact of unaidable hearing impairment on cognitive impairment in precarious and non-precarious patients.	through study completion an average of 1 year	to evaluate and compare: Cognitive impairment established by MMSE score (2 groups with mild and moderate/severe impairment) according to the presence or absence of hearing impairment and according to the presence or absence of precariousness (according to EPICES score \> 30 or ≤ 30, respectively).

Trial Locations

Locations (1)

Service de neurologie; 🇫🇷 Bobigny, France