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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.

Conditions
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Hearing Loss

Intervention / Treatment
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* Radiation: PET examination
* Other: Quality of life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient and control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Presbycusis<br>Patients with presbycusis who receive rehabilitation with hearing aids | Radiation: PET examination<br>* PET examinations with auditory stimuli such as human voice and environmental sounds.<br>Other: Quality of life assessment<br>* quality of life assessment by : Speech, Spatial and Qualities of Hearing Hearing Handicap Inventory For The Elderly Screening Short Form Health Survey<br>|
| Active Comparator: Aged control group<br>Aged control group: 15 subjects with normal or near-normal hearing thresholds | Other: Quality of life assessment<br>* quality of life assessment by : Speech, Spatial and Qualities of Hearing Hearing Handicap Inventory For The Elderly Screening Short Form Health Survey<br>|
| Active Comparator: Young control group<br>Young control group: 15 subjects with normal hearing thresholds | Radiation: PET examination<br>* PET examinations with auditory stimuli such as human voice and environmental sounds.<br>Other: Quality of life assessment<br>* quality of life assessment by : Speech, Spatial and Qualities of Hearing Hearing Handicap Inventory For The Elderly Screening Short Form Health Survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of brain activity | level of brain activity (in ml/100g/min) measured in the auditory regions in PET when the subject performs a spatial localization task | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life quality by Speech, Spatial and Qualities of Hearing (12) | Speech, Spatial and Qualities of Hearing is a questionnaire specific to the quality of hearing. It has 3 sections; speech hearing, spatial hearing and quality of hearing. This questionnaire contains 15 items evaluated on a scale to 0 (not at all) to 10 (perfectly). | Month 12 | 
| Life quality by Speech, Spatial and Qualities of Hearing (6) | Speech, Spatial and Qualities of Hearing is a questionnaire specific to the quality of hearing. It has 3 sections; speech hearing, spatial hearing and quality of hearing. This questionnaire contains 15 items evaluated on a scale to 0 (not at all) to 10 (perfectly). | Month 6 | 
| life quality by Hearing Handicap Inventory For The Elderly Screening (12) | Hearing Handicap Inventory For The Elderly Screening contains 10 items to identify the social and emotional difficulties encountered by the subject due to his deafness according to specific situations. It makes it possible to detect the handicap perceived by the person (the higher the score, the greater the perception of the handicap due to hearing loss). | Month 12 | 
| life quality by Hearing Handicap Inventory For The Elderly Screening (6) | Hearing Handicap Inventory For The Elderly Screening contains 10 items to identify the social and emotional difficulties encountered by the subject due to his deafness according to specific situations. It makes it possible to detect the handicap perceived by the person (the higher the score, the greater the perception of the handicap due to hearing loss). | Month 6 | 
| life quality by Short Form Health Survey (12) | Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items. | Month 12 | 
| life quality by Short Form Health Survey (6) | Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items. | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, Presbycusis, Auditory cortex., Auditory plasticity., Localization, Speech-in-noise