Clinical trial NCT05149742: Deafness and Cognition in Middle-aged Adults
Official title: Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment in Middle-aged Adults
Keywords: Severe and profound hearing loss
mild cognitive impairment (MCI)
middle aged adult
depression
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 180
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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)

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

Primary outcomes:
measure: Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: Evaluation of 16-item Free and Cue Selective Recall Test (RLRI/16) to evaluate episodic memory in patients with severe to profound hearing loss compare to subjects with normal hearing
timeFrame: 1 day
measure: Evaluation of Digit Symbol Substitution Test to evaluate psychomotor speed and executive functions, executive functions in patients with severe to profound hearing loss compare to subjects with normal hearing
timeFrame: 1 day
measure: Evaluation of Instrumental activities of daily living scale to evaluate the level of dependence of dependence of the subjects in patients with severe to profound hearing loss compare to subjects with normal hearing
timeFrame: 1 day
measure: Evaluation of Cognitive Complaint Questionnaire to evaluate Cognitive assessment in patients with severe to profound hearing loss compare to subjects with normal hearing
timeFrame: 1 day
Secondary outcomes:
measure: Type of MCI
timeFrame: 1 day
measure: Impact of the severity of the hearing loss on presence and severity of cognitive disorders
timeFrame: 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle Dr MOSNIER, MD
role: PRINCIPAL_INVESTIGATOR
References: