Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Neuropsychiatric tests scores
研究概览
简要总结
Alzheimer disease is the most common neurodegenerative brain disease that causes cognitive impairment in the elderly but also behavioral and psychological symptoms. Among these symptoms, agitation is one of the most dangerous because it put the patient and their caregivers in danger. Sleep disorders can be the cause of many psychiatric symptoms leading directly or indirectly to agitation. Music therapy is the non-drug therapy which has been shown to be the most effective in managing agitation and sleep disorders. With the MAGE protocol, the investigators propose to take care of behavioral disorders in severe Alzheimer patients living in nursing home through sequences of music therapy (stimulation, relaxation) automatically initiated by an actigraph that will detect sleep disorders. These subjects will be exposed for 2 weeks over a month. Behavioral and sleep disorders will be evaluated objectively by actigraphy but also by standardized scales, as the others neuropsychiatric symptoms found classically in this disease. Thanks to this project, the investigators hope to improve the quality of life of these patients by preventing them from putting themselves in danger, by reducing their neuropsychiatric symptoms and their use of medication, which has often deleterious side effect and also by reducing the workload of caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years old
- •Male or Female
- •Patients with a diagnosis of Alzheimer disease according to the criteria of NINCDS-ADRDA or typical or atypical Alzheimer disease
- •MMSE < 20
- •Patient residing in nursing home
- •Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator)
- •Affiliation to a social security system
排除标准
- •Prescription of a new psychotropic treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in week prior to the evaluation
- •Hearing loss preventing the patient from responding perfectly to the therapeutic solutions provided
研究组 & 干预措施
Music therapy
Patients will be exposed every two weeks
干预措施: Music Therapy (Procedure)
结局指标
主要结局
Neuropsychiatric tests scores
时间窗: At 3 months
NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120
Nightly agitation
时间窗: At 3 month
The number of movements of the patient by the actigraphy, before exposure and at the end of each exposure
次要结局
- Rate of anxiety(At 3 months)
- Sleeping troubles(At 3 months)
- Number of falls(At 3 months)