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临床试验/NCT02829892
NCT02829892已完成不适用

Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Sleep duration between 10 p.m to 5 a.m

研究概览

简要总结

Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light nighttime sleep of residents.

详细描述

Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment. In 2014, the Cochrane published a systematic review of the literature over the last 20 years concerning the use of light therapy in patients with a AD. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light therapy (from 5 a.m to 10 p.m) on nighttime sleep of residents. Secondary objectives were the study of sleep time on the day, anxiety by the COVI scale and behavioral disorders by the NPI scale.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • EHPAD residents at Les Pastoureaux Valenton having moderate to severe MASA
  • More than 60 years
  • Presenting motor behavioral disorders and / or anxiety and / or restlessness and / or insomnia .
  • No underlying acute medical problems including no delirium

排除标准

  • Residents refusing to lend to experimentation
  • Resident who are not matching with the inclusion criteria
  • total acquired or congenital blindness
  • bedridden patient ( loss of physical autonomy)
  • Entry to the residence less than 15 days before the start of the experiment.

结局指标

主要结局

Sleep duration between 10 p.m to 5 a.m

时间窗: 14 days

次要结局

  • Number of awake between 10 p.m to 5 a.m(14 days)
  • Anxiety by the COVI scale(14 days)
  • Sleep duration by day(14 days)
  • Behavioral disorders by the NPI scale(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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