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

NCT06478888 | Not Yet Recruiting

• 1 other identifier: APHP240443
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Keywords

cognitive disorders; hearing impairment; precariousness

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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.

  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

  through study completion an average of 1 year

• Other neuropsychological tests to assess cognitive functions such as praxis and visual-spatial perception

  through study completion an average of 1 year

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cognitive problems associated with hearing impairment and/or precariousness

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de neurologie

Bobigny, 93000, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Hearing Loss

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arnaud LAPOSTOLLE, Dr

CONTACT

01 48 95 54 01; arnaud.lapostolle@aphp.fr

Bertrand Degos

CONTACT

01 48 95 54 00; bertrand.degos@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 27, 2024
• Study Start: May 1, 2025
• Primary Completion: May 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

FR (1)