RecruitingRecruiting
Deafness and Cognition in Middle-aged Adults
NCT05149742 · Assistance Publique - Hôpitaux de Paris
In plain English
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Official title
Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults
About this study
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)
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
Study design
Enrollment target: 180 participants
Allocation: non_randomized
Masking: none
Age groups: adult
Timeline
Starts: 2022-05-24
Estimated completion: 2027-05-24
Last updated: 2025-09-15
Interventions
Behavioral: Cognitive and audiometry evaluation
Primary outcomes
- • Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing (1 day)
- • Evaluation of Trail making tests (TMT) A et B to evaluate executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing (1 day)
- • Evaluation of "Fluences verbales sémantique et phonémique" to evaluate linguistic skills in patients with severe to profound hearing loss compare to subjects with normal hearing (1 day)
Sponsor
Assistance Publique - Hôpitaux de Paris · other
Contacts & investigators
ContactIsabelle Dr MOSNIER, MD · contact · isabelle.mosnier@aphp.fr · 142162612
ContactNassima SCHMOLL · contact · nassima.schmoll@aphp.fr · 142163089
InvestigatorIsabelle Dr MOSNIER, MD · principal_investigator, Assistance Publique - Hôpitaux de Paris
All locations (1)
Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-SalpêtrièreRecruiting
Paris, France