Clinical Trial on Cognitive, Behavioural, Quality of Life and Medico-economic Benefits of Hearing Aids in Alzheimer Disease Patients Suffering From Presbycusis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Cognitive benefit evaluated thanks to the ADAS-Cog scale
研究概览
简要总结
This is a 12-months' randomized clinical trial that aims at studying the benefit of bilateral hearing aids in hearing impaired patients suffering from a slight to moderate stage Alzheimer disease.
The benefit of this intervention will be studied in the cognitive, behavioural, quality of life and economic fields.
2groups are involved in this trial: Intervention group: 12 months' treatment with active hearing aids, fitted hearing impairment Control group: 6 months' treatment with placebo hearing aids, followed with 6 months' active hearing aids, fitted hearing impairment
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 (Participant, Investigator)
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
- •> 65 year-old
- •Medical diagnosis of Alzheimer disease
- •15 ≤ MMSE ≤ 25
- •No hearing aids in the last 2 years
- •Motivated caregiver living with the patient
- •Sensorineural hearing loss
排除标准
- •Beginning of an anticholinesterasic treatment in the last 6 months
- •Change in the anticholinesterasic treatment in the last 2 months
研究组 & 干预措施
Active Hearing aids
Active
干预措施: Hearing aids used : PHONAK Savia and Valeo (Device)
Inactive Hearing aids
Hearing aids turned off
干预措施: Hearing aids used : PHONAK Savia and Valeo (Device)
结局指标
主要结局
Cognitive benefit evaluated thanks to the ADAS-Cog scale
时间窗: Times of measurements: 0, 6th and 12th month
次要结局
- Quality of life scales: Zarit scale and ADRQL(Zarit scale(every 2 months during the study time), ADRQL (0, 6th and 12th month))
- Consumption questionnaire(monthly)
- Cognitive scales: MMSE, Grober and Buschke, Digit symbol test(0, 6th and 12th month)
- Behavioural scales: IADL, NPI(1st week, 3rd 6th 9th and 12th month)