Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- level of brain activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
level of brain activity
时间窗: 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
次要结局
- life quality by Hearing Handicap Inventory For The Elderly Screening (12)(Month 12)
- life quality by Hearing Handicap Inventory For The Elderly Screening (6)(Month 6)
- Life quality by Speech, Spatial and Qualities of Hearing (6)(Month 6)
- Life quality by Speech, Spatial and Qualities of Hearing (12)(Month 12)
- life quality by Short Form Health Survey (12)(Month 12)
- life quality by Short Form Health Survey (6)(Month 6)