Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
研究概览
简要总结
Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction.
Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric tests as noisy and/or dichotic tests, are needed.
Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease; therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now, investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored the hearing ability of the patient. However, the major part of care management and investigations implies the patient's communication ability with caregivers. Hearing loss may be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline but this management must be investigate during longitudinal studies in order to demonstrate their efficiency and need to be compared with a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer patient
- •Mini Mental state examination= 15-25 or mild cognitive impairment
- •Over 65 yo
- •Sensorineural hearing loss with pure tone average over 30 dB
- •Language: French
- •Able to sign the consent
- •Affiliated to the French social security
排除标准
- •Conductive hearing loss
- •Retrocochlear hearing loss
- •History of neurological disorders with consequences in hearing loss (vascular accident; brain surgery, cerebral tumors, head trauma with loss consciousness)
- •patient included in another study
- •French no spoken
- •chronic used of drugs or alcohol
结局指标
主要结局
Changing score in Cognitive functions measured with Alzheimer's Disease Assessment Scale-cognitive scale
时间窗: Change before and one year after the fitting with device
French scale validated by the french society of geriatry
次要结局
- Speech Discrimination Test (%) measured by speech audiometry(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Dichotic test measured with audiometry(From 1 to 90 days prior the fitting with device)
- Amplification with hearing aids or placebo devices measured by tonal and speech audiometry (dB HL)(6 months after the fitting with device, 12 months after the fitting with device)
- Speech recognition threshold (dB HL) measured by speech audiometry(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Objective auditory thresholds measured with auditory brainstem responses (ms)(6 months after the fitting with device, 12 months after the fitting with device)
- Objective auditory thresholds measured by Auditory steady state responses (in dB eHL)(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Hearing Handicap Inventory for Elderly measured by questionnaire (10 items, total score from 0-40)(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Executive functions measured by trail making test(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Assessing caregiver burden measured by Zarit scale (22 items, total score from 0-88)(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- air and bone auditory thresholds (dB HL) measured at 500, 1000, 2000, 3000 and 4000 Hz(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Devices tolerance measured with number of hours per day with hearing aids(6 months after the fitting with device, 12 months after the fitting with device)
- Mini Mental State Examination (30 items, total score from 0-30)(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Hearing loss impact scale in adults measured by 2 questionnaire (Abbreviated Profile of Hearing Aid Benefit, 24 items) and Impact of hearing loss in adults (20 items, total score from 0-200)(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Quality of life-Alzheimer disease scale measured by questionnaire (total score from 13-52)(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Speech comprehension measured by Beauregard tests(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Depression in the elderly measured by Geriatric depression scale (30 items, total score from 0-30)(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Working memory and processing speed measured by Wechsler Adult Intelligence Scale(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)
- Hearing aids tolerance measured by Glagow hearing-aid benefit questionnaire(From 1 to 90 days prior the fitting with device, 6 months after the fitting with device, 12 months after the fitting with device)