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临床试验/NCT00946530
NCT00946530已完成不适用

Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

Stanford University2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2004年9月最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
118
试验地点
2
主要终点
Total Sleep Time
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study is to demonstrate the efficacy of timed exposure to bright light for the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia patients and their caregivers, and to determine if there are genetic relationships between memory problems and sleep problems

详细描述

  1. Efficacy: Up to 4 weeks of morning bright light exposure will be more efficacious than morning dim light in consolidating nighttime sleep as assessed by actigraphy.
  2. Predictors of response: We expect the primary predictor of treatment response will be initial MMSE score. Secondary predictors include baseline sleep/wake and circadian parameters and age.
  3. Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life.
  4. An understanding of some of the genetic markers of memory and/or sleep problems.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 100 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Alzheimer's Disease Patients:
  • •Stanford Alzheimer's Disease Core Center member or potential member, with diagnostic criteria met for probable AD, living with caregiver willing to participate in the protocol
  • •Non-institutionalized
  • •Caregivers:
  • •Living in home of AD patient and willing to participate in protocol

排除标准

  • •Alzheimer's Disease Patients:
  • •History of manic or bipolar disorder
  • •Prior bright light treatment
  • •Irregular or non-24 hour sleep/wake cycle
  • •Positive result on multi-staged RLS/PLMD
  • •Medical/Ophthalmologic Exclusions
  • •RDI >20 on overnight EdenTrace® recording
  • •Caregivers:
  • •History of manic or bipolar disorder
  • •Medical/Ophthalmologic Exclusions

研究组 & 干预措施

Bright Light

Experimental

received bright light

干预措施: Bright light (Device)

Control

Placebo Comparator

received regular light

干预措施: Control (Device)

结局指标

主要结局

Total Sleep Time

时间窗: 2 weeks

The amount of actual sleep time in a sleep episode.

次要结局

  • WASO (Wake After Sleep Onset)(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerome A Yesavage,

Professor of Psychiatry

Stanford University

研究点 (2)

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