Light Treatment for Sleep/Wake Disturbances AD

描述（由申请人提供）：阿尔茨海默病（AD）是痴呆症最常见的原因。许多AD患者出现睡眠/觉醒周期紊乱。我们提出了一个随机对照临床试验，仔细评估这些问题的非药物方法。我们的具体目标和假设是：1）有效性。我们计划比较四种治疗对社区居住AD患者睡眠/觉醒周期紊乱的短期疗效：1）早晨强光治疗（AM LIGHT），2）晚上强光治疗（PM LIGHT），3）早晨和晚上强光治疗（AM&PM LIGHT）和4）对照治疗，早晨昏暗光治疗（AM DIM）。假设1：我们假设4周的AM LIGHT、PM LIGHT或AM&PM LIGHT治疗在巩固夜间睡眠方面比AM DIM治疗更有效，如通过体动记录仪评估的那样。我们不希望看到AM LIGHT、PM LIGHT和AM&PM LIGHT之间的总体疗效差异。 2)反应的个体差异（调节剂）。我们将进行初步的“主持人分析”，以确定哪些患者的LIGHT治疗效果最好。假设2：反应的主要预测因素：对LIGHT治疗的反应将取决于初始MMSE评分。次要预测因素分析：我们预计基线睡眠/觉醒和昼夜节律参数和年龄可以预测AM光与PM光的反应。 3)有效性和生活质量。我们将确定明亮的光疗法在改善生活质量方面是否有效。假设3：我们假设三种LIGHT治疗中的任何一种都比AM DIM更有效地改善患者和护理人员的生活质量。 这些假设将在社区居住的AD患者与照顾者的平行组设计研究中进行测试。具体来说，我们建议将120名患者/护理人员随机分为四组，每组30名：上午光，下午光上午和下午光或上午调光。治疗4周后（第1阶段），所有受试者将给予明亮的光额外4周（第2阶段）。将通过客观昼夜活动节律参数和标准睡眠/觉醒测量记录结局，两者均通过体动记录仪进行评估。

DESCRIPTION (provided by applicant): Alzheimer's Disease (AD) is the most common cause of dementia. Many AD patients develop sleep/wake cycle disturbances. We propose a randomized controlled clinical trial to carefully evaluate a non-pharmacologic approach to these problems. Our specific aims and hypotheses are: 1) Efficacy. We plan to compare the short-term efficacy of four treatments for sleep/wake cycle disturbances in community-dwelling AD patients: 1) Morning bright light treatment (AM LIGHT), 2) Evening bright light treatment (PM LIGHT), 3) Morning and Evening bright light treatment (AM&PM LIGHT) and 4) a control treatment, morning dim light treatment (AM DIM). Hypothesis 1: We hypothesize that 4 weeks of either AM LIGHT, PM LIGHT or AM&PM LIGHT treatment will be more efficacious than the AM DIM treatment in consolidating nighttime sleep as assessed by actigraphy. We do not expect to see overall differences in efficacy between AM LIGHT, PM LIGHT and AM&PM LIGHT. 2) Individual Differences in Response (Moderators). We will conduct preliminary "moderator analyses" to determine in which patients which LIGHT treatment works best. Hypothesis 2: Primary Predictors of Response: Response to the LIGHT treatments will depend upon the initial MMSE score. Secondary Predictor Analyses: We expect that baseline sleep/wake and circadian parameters and age may predict response to AM LIGHT versus PM light. 3) Effectiveness and Quality of Life. We will determine if bright light therapy is effective in terms of improvement in quality of life. Hypothesis 3: We hypothesize that any of the three LIGHT treatments will be more effective than AM DIM in improving quality of life in patients and caregivers. These hypotheses will be tested in a parallel groups design study in community-dwelling AD patients with caregivers. Specifically, we propose to randomize 120 patient/caregiver dyads into four groups of 30 dyads each: AM LIGHT, PM LIGHT AM&PM LIGHT or AM DIM. After 4 weeks of treatment (Phase 1) all subjects will be given bright light for an additional 4 weeks (Phase 2). Outcome will be documented by objective circadian activity rhythm parameters and standard sleep/wake measures both assessed by actigraphy.