Deafness and Cognition in Middle-aged Adults

NCT ID: NCT05149742

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-24
• Study Completion Date: 2027-05-24

Brief Summary

A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years. The aim of our study was to compare cognitive function between patients with severe and profound hearing loss and patients with normal hearing in patients aged 45 to 64 years.

Detailed Description

This case-control study will include 180 middle aged adults (90 cases, 90 healthy controls) matched on sex, age, education level in order to find an association between severe and profound hearing loss and presence of mild cognitive impairment.

90 subjects with severe to profound hearing loss,, with a maximum speech intelligibility of 70% for Fournier's disyllabic words in silence with properly fitted hearing aids could be included. Cognition evaluated on a battery of 5 tests, depression and dependance will be compared to healthy controls with normal hearing on pure-tone audiometry (as function of ISO 7029 reference) The subjects (cases and controls) will be recruited in the ENT consultation from the Cochlear Implant Center (Unité fonctionnelle implants auditifs, Pitié-Salpêtrière Hospital, Head: Dr Isabelle Mosnier)

Conditions

Mild Cognitive Impairment in Middle-aged Adults

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cases: Patients with severe to profound hearing loss

Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL

Group Type: EXPERIMENTAL

Cognitive and audiometry evaluation

Intervention Type: BEHAVIORAL

For both Patients and controls:

• Cognitive functions evaluation
• Tonal and vocal audiometry
• Self questionnaires

Controls: 90 matched subjects with normal hearing

Healthy controls aged between 45 to 64 years with normal hearing on pure-tone audiometry (as function of ISO 7029 reference)

Group Type: ACTIVE_COMPARATOR

Cognitive and audiometry evaluation

Intervention Type: BEHAVIORAL

For both Patients and controls:

• Cognitive functions evaluation
• Tonal and vocal audiometry
• Self questionnaires

Interventions

Cognitive and audiometry evaluation

For both Patients and controls:

• Cognitive functions evaluation
• Tonal and vocal audiometry
• Self questionnaires

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Cases: Patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 dB SPL, current in french
• Controls: normal hearing subjects matched on age, sex and education level

Exclusion Criteria

• Associated disability that prevents the tests from being performed
• Past and current history of neurological and psychiatric disorders including meningitis
• Psychotropic drug treatment
• Vulnerable subject

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Dr MOSNIER, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle Dr MOSNIER, MD

Role: CONTACT

isabelle.mosnier@aphp.fr

142162612 ext. +33

Nassima SCHMOLL

Role: CONTACT

nassima.schmoll@aphp.fr

142163089 ext. +33

Facility Contacts

Isabelle Dr MOSNIER, MD

Role: primary

isabelle.mosnier@aphp.fr

142162612 ext. +33

Other Identifiers

APHP210439

Identifier Type: -

Identifier Source: org_study_id