Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population. (AGEHEAR)

Toulouse University Hospital

Status: Enrolling

Conditions: Hearing Loss

Treatments: Other: Quality of life assessment; Radiation: PET examination

Study type: Interventional

Funder types: Other

Identifiers

NCT05331404

RC31/20/0365

2021-A01993-38 (Other Identifier)

Details and patient eligibility

About

Hearing aids restore efficiently some auditory functions in age-related hearing loss (ARHL or presbycusis) providing to the elderly an access to oral communication and a return to social life. However, a most of the assessments of their efficacy focus on speech recognition. Spatial hearing and localization are anothers important auditory functions merely evaluated.

The purpose of this study is to evaluate the hearing aids benefits for spatial hearing.

Full description

The main objective is to evaluate the hearing aids benefits for spatial hearing with a multidisciplinary approach combing psychophysics, and Positron Emission Tomography (PET) brain imaging in a before/after experimental design. The novelty of the proposal is both theoretical and methodological: the team aim is to identify neural correlates of spatial hearing after hearing rehabilitation and evaluate the evolution of spatial hearing abilities once subjects with presbycusis are fitted with hearing aids. The assessment of spatial hearing processing will rely on both a virtual visuo-auditory 3D immersive platform and functional neuroimaging using PET scan. This project will provide crucial elements for understanding and improving the rehabilitation of age-related hearing loss.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For presbyacusics subjects:

• Subjects aged over 50 with a difference in symmetrical audiometric thresholds (< 15 dB) between the two ears and requiring hearing aids
• Affiliation to a social security scheme or equivalent
• Acceptance of the protocol and signature of the consent form

For older people with normal hearing:

• Subjects matched in age (+/- 2 years) and gender with the presbycusis group
• Affiliation to a social security scheme or equivalent
• Acceptance of the protocol and signature of the consent form
• Subjects with normal hearing, with hearing thresholds of 20 dB < 2kHz and 40 dB < 4kHz

For young people with normal hearing:

• Subjects aged between 18 and 40 years old,
• Symmetric normal hearing
• Affiliation to a social security scheme or equivalent
• Normally hearing subjects with audiometric thresholds < 20 dB
• Acceptance of the protocol and signature of the consent form

Exclusion criteria

• Persons under a legal protection regime for adults (safeguard of justice, guardianship, curator ship, institutionalized, or under mandate for future protection)
• History of associated neurological pathology
• Contraindications to PET
• Cognitive impairment confirmed by the Montreal Cognitive Assessment (MOCA) test (for presbyacusic subjects and normal-hearing elderly subjects)
• Taking psychotropic drugs
• History of epilepsy
• Pregnant or breastfeeding woman
• Participation in another intervention protocol

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Presbycusis

Experimental group

Description:

Patients with presbycusis who receive rehabilitation with hearing aids

Treatment:

Radiation: PET examination

Other: Quality of life assessment

Aged control group

Active Comparator group

Description:

Aged control group: 15 subjects with normal or near-normal hearing thresholds

Treatment:

Other: Quality of life assessment

Young control group

Active Comparator group

Description:

Young control group: 15 subjects with normal hearing thresholds

Treatment:

Radiation: PET examination

Other: Quality of life assessment