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临床试验/NCT01650454
NCT01650454
已完成
不适用

Sleep, Cognition and Memory Disorder

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 58 人2013年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Sleep Architecture
发起方
University Hospital, Bordeaux
入组人数
58
试验地点
1
主要终点
Polysomnography of night 1
状态
已完成
最后更新
4年前

概览

简要总结

The increasing incidence of Alzheimer's disease (AD) and related sleep-disorders with the aging of the population is a major issue of public health. The prevalence of sleep disturbances is about 50% in dementia patients. Sleep in dementia is mainly characterized by prolonged night-time awakenings, sometimes with longer sleep latency and/or early awakening. The presence of these sleep disturbances is the main reason for the institutionalization of AD patients, as well as a major cause of the deterioration of the caregivers' sleep. The MEMENTO cohort is composed of patients with isolated memory complaints or mild cognitive impairment, at high risk to develop dementia. All voluntary patients from the CMRR (Center of Memory, resources and Research) of Bordeaux (MEMENTO cohort) will be tested at inclusion and followed-up 1 year later. For these two evaluations, actigraphic monitoring at home, 2-night polysomnography (PSG) monitoring at hospital including a 24-hour period of urinary melatonin dosage, neuropsychological tests battery, a virtual reality tool and questionnaires will be used.

注册库
clinicaltrials.gov
开始日期
2013年1月
结束日期
2015年10月29日
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University Hospital, Bordeaux
责任方
Sponsor

入排标准

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Polysomnography of night 1

时间窗: Change from inclusion (Month 0) and Month 12

Actimetry: Inter-daily stability, intra-daily variability, rhythm amplitude

次要结局

  • Subjective evaluation of sleep and Somnolence(Month 0 and Month 12)
  • Evaluation of Memory disorder(Month 0 and Month12)

研究点 (1)

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