Deafness and Cognition in Middle-aged Adults (SURDICOG)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Mild Cognitive Impairment in Middle-aged Adults

Treatments: Behavioral: Cognitive and audiometry evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05149742

APHP210439

Details and patient eligibility

About

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.

Full 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)

Enrollment: 180 estimated patients

Sex: All

Ages: 45 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Cases: Patients with severe to profound hearing loss

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive and audiometry evaluation

Controls: 90 matched subjects with normal hearing

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive and audiometry evaluation