Sweet Night (Musical Diffusion by Caregivers ): Effects of Musical Diffusion by Caregivers on Sleep Onset and Behavioral Regulation in a Protected Living
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sleep duration
研究概览
简要总结
As the Alzheimer's disease progresses, caregivers and family members often focus on behavioral difficulties. In response to crises, immediate actions tend to favor restraints, either through medication or physical means. This work aims to improve the management of behavioral disturbances in patients with Alzheimer's disease through musical interventions (group or individual), particularly in advanced stages of the disease, where medical and family resources are insufficient. The investigators approach prioritizes NTM over medication as a mean to improve patient well-being. To this end, they have designed a study. The study focuses on creating a conducive environment for sleep by incorporating ritualized, familiar music sessions supervised by nursing staff after meals. To conduct this study, the actigraphy will be used to analyze participants' behavior both day and night, complemented by questionnaires and clinical observations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Non-opposition of the patient's legal guardian.
- •Patients aged 60 and over, meeting the diagnostic criteria for Alzheimer's disease and related disorders.
- •Patients living in a Protected Living Unit (PLU)
- •If consuming psychotropic medications, they must have been stabilized for 3 months.
- •If consuming level 2 or 3 analgesics, they must have been stabilized for 1 month.
排除标准
- •Refusal to participate.
- •Participation in a study on a drug /medical device / care technique that could affect sleep or behavior during the study.
研究组 & 干预措施
Passive EXPERIMENT
Measurement of the effects of a personalised music listening session at bedtime (play-list) for 10 days. Each patient is his or her own control. Behavioural and actigraphic data are collected and compared before, during and after the intervention.
干预措施: Music intervention - passive listening (Behavioral)
Active EXPERIMENT
An intervention based on listening to audio books, led by a therapist for 10 evenings . Each patient is his or her own control and takes part in the entire experiment. Behavioural and actigraphic data are collected and compared before, during and after intervention.
干预措施: Audio books intervention - active listening (Behavioral)
结局指标
主要结局
Sleep duration
时间窗: Days 1 to 51
Sleep duration will be measured by actigraphy (bracelet worn by the participants).
次要结局
- Sleep onset and nocturnal awakenings reduction(Days 1 to 51)
- Daytime agitation reduction(Days 1 to 51)
- Mood improvement(Days 1 to 51)
- Falls number reduction(Days 1 to 51)