Deafness and Cognition in Middle-aged Adults
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive and audiometry evaluation.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment in Middle-aged Adults. Basic parameters: 45 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults
Overview
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)
Interventions
- Behavioral Cognitive and audiometry evaluation
For both Patients and controls: * Cognitive functions evaluation * Tonal and vocal audiometry * Self questionnaires
Primary outcome measures
- Evaluation of Mini Mental State Examination to access cognitive impairment in patients with severe to profound hearing loss compare to subjects with normal hearing [Time frame: 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 [Time frame: 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 [Time frame: 1 day]
- 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 [Time frame: 1 day]
- 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 [Time frame: 1 day]
- 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 [Time frame: 1 day]
- Evaluation of Cognitive Complaint Questionnaire to evaluate Cognitive assessment in patients with severe to profound hearing loss compare to subjects with normal hearing [Time frame: 1 day]
Secondary outcome measures (2)
- Type of MCI [Time frame: 1 day]
- Impact of the severity of the hearing loss on presence and severity of cognitive disorders [Time frame: 1 day]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-Salpêtrière — Paris
Identifiers
NCT: NCT05149742 · APHP210439