Light Treatment for Sleep/Wake Disturbances AD

阿尔茨海默病(AD)是导致痴呆症的最常见原因。许多AD患者出现睡眠/觉醒 周期干扰。我们建议进行一项随机对照临床试验，仔细评估 解决这些问题的非药理学方法。我们的具体目标和假设是： 1)功效。我们计划比较四种治疗睡眠/清醒周期紊乱的短期疗效。 社区居住的AD患者：1)早晨强光治疗(AM光)，2)晚上强光治疗 处理(PM光)，3)早晚强光处理(AM和PM光)和4)对照 治疗，晨光治疗(AM DIMM)。假设1：我们假设任何一个AM的4周 光、PM光或AM&PM光处理将比AM暗处理更有效 通过动作记录仪评估巩固夜间睡眠。我们预计不会看到总体上的差异 AM灯、PM灯和AM&PM灯之间的功效。 2)回答的个体差异(主持人)。我们会进行初步的“主持人分析”，以 确定哪些患者接受哪种光线治疗效果最好。假设2：主要预测因素 反应：对光处理的反应将取决于初始的MMSE分数。次要的 预测分析：我们预计基线睡眠/清醒、昼夜节律参数和年龄可以预测 对AM光和PM光的响应。 3)有效性和生活质量。我们将确定强光疗法在以下方面是否有效 生活质量的提高。假设3：我们假设三种光疗法中的任何一种都将是 在改善患者和照顾者的生活质量方面比AM DIM更有效。 这些假说将在一项平行分组设计研究中得到验证，研究对象为社区居住的AD患者 照顾者。具体地说，我们建议将120名患者/照顾者对偶随机分成四组，每组30对 每一种：AM灯、PM灯、AM&PM灯或AM暗灯。经过4周的治疗(第一阶段)，所有受试者 将给予额外4周的明亮光线(第二阶段)。结果将由目标进行记录 昼夜活动节律参数和标准睡眠/觉醒测量均由活动记录仪评估。

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 nonpharmacologic 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.