Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.
- Conditions
- Hearing Loss
- Interventions
- Radiation: PET examinationOther: Quality of life assessment
- Registration Number
- NCT05331404
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Presbycusis Quality of life assessment Patients with presbycusis who receive rehabilitation with hearing aids Young control group PET examination Young control group: 15 subjects with normal hearing thresholds Young control group Quality of life assessment Young control group: 15 subjects with normal hearing thresholds Presbycusis PET examination Patients with presbycusis who receive rehabilitation with hearing aids Aged control group Quality of life assessment Aged control group: 15 subjects with normal or near-normal hearing thresholds
- Primary Outcome Measures
Name Time Method level of brain activity Month 12 level of brain activity (in ml/100g/min) measured in the auditory regions in PET when the subject performs a spatial localization task
- Secondary Outcome Measures
Name Time Method life quality by Hearing Handicap Inventory For The Elderly Screening (12) Month 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).
life quality by Hearing Handicap Inventory For The Elderly Screening (6) Month 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).
Life quality by Speech, Spatial and Qualities of Hearing (6) Month 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).
Life quality by Speech, Spatial and Qualities of Hearing (12) Month 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).
life quality by Short Form Health Survey (12) Month 12 Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
life quality by Short Form Health Survey (6) Month 6 Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items.
Trial Locations
- Locations (1)
CHU Toulouse
🇫🇷Toulouse, France