TREATMENTS FOR INSOMNIA

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。关于明亮的光治疗失眠的文献中存在一些空白：1）尚未在足够的受试者中进行研究，以充分了解其改善基本睡眠测量的有效性，包括通过活动记录仪和多导睡眠图（PSG）获得的那些; 2）一天中最佳治疗时间的问题尚未解决; 3）我们不知道治疗效果持续多久; 4）我们不知道治疗效果是否在某些受试者中比其他人更好; 5）我们不知道作用机制; 6）最后，即使这种疗法影响睡眠指标，也不知道它是否也影响生活质量指标。我们计划通过测试以下假设来解决这些差距：疗效我们计划评估三种非药物治疗老年人失眠症的短期和长期疗效：1）行为治疗，采用睡眠卫生的基本原则来改善睡眠，除了睡眠卫生原则外，还定时暴露于明亮的光线; 2）早上提供光线，或;（3）晚上送灯。我们假设，与单独使用Hygiene相比，与Hygiene结合使用时，明亮的光疗法将具有显着的累加效应。主要结果测量将是总睡眠时间，入睡后觉醒，以及通过活动记录仪记录的睡眠效率。我们希望这些结果不仅在3个月治疗期结束时出现，而且在3个月随访期间也会出现。 个体反应差异（调节因子）我们预计，根据治疗前受试者昼夜节律测量的相位、幅度或同步程度，两种卫生和光照治疗的疗效将存在个体差异。这个建议为我们提供了一个机会，以初步的方式，昼夜节律标志物和时钟基因等位基因状态的能力，以预测治疗反应的一组失眠患者。 作用机制（介体）我们预计，治疗期间昼夜节律测量的相位、振幅或同步程度的变化可能是观察到的一些治疗效应的原因。为了检验这一假设，将评估治疗期间四种昼夜节律标志物的变化：睡眠/觉醒、休息/活动、褪黑激素分泌和核心体温。 生活质量我们将确定这两种光疗法是否对失眠有效相对于卫生方面的健康相关的生活质量的影响。这些假设将在三个条件下以平行组设计进行测试：卫生，卫生和晨光，以及卫生和黄昏。每日治疗将持续三个月，治疗结束后，患者将接受为期三个月的每月一次的随访。这将最终包括90名年龄>60岁的治疗受试者（三组，每组30名），对每种条件下的所有受试者进行PSG记录、体动记录、自我报告、昼夜节律测量和基因分型。 这项为期五年的提案最终将包括90名年龄>60岁的治疗受试者（三组，每组30名），对每种情况下的所有受试者进行PSG记录、体动记录、自我报告、昼夜节律测量和基因分型。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There are a number of gaps in the literature about bright light treatment for insomnia: 1) It has not been studied in enough subjects to fully understand its efficacy on improving basic sleep measures including those obtained by actigraphy and polysomnography (PSG); 2) The issue of the best time of day for treatment delivery has not yet been resolved; 3) We do not know how long treatment effects last; 4) We don't know whether treatment efficacy is greater in some subjects than others; 5) We don't know the mechanisms of action; and 6) Finally, even if this therapy affects sleep measures, it is unknown whether it also affects measures of quality of life. We plan to address these gaps by testing the following hypotheses: Efficacy We plan to evaluate the short-term and long-term efficacy of three nonpharmacologic treatments for insomnia in older adults: 1) a behavioral treatment that employs the basic principles of sleep hygiene to improve sleep and timed exposure to bright light in addition to sleep hygiene principles with; 2) light delivered in the morning, or; 3) light delivered in the evening. We hypothesize that bright light therapy will have a significant additive effect when combined with Hygiene compared to Hygiene alone. Primary outcome measures will be total sleep time, wake after sleep onset, and sleep efficiency as recorded by actigraphy. We expect that these results will be present not only at the end of the 3-month treatment period, but also over a 3-month follow-up. Individual Differences in Response (Moderators) We expect that there will be individual differences in the efficacy of the two Hygiene and Light treatments depending upon the phase, amplitude, or the degree of synchronization of subjects circadian rhythm measures demonstrated prior to treatment. This proposal provides us the opportunity to examine, in a preliminary manner, the ability of circadian markers and CLOCK gene allele status to predict treatment response in a group of patients with insomnia. Mechanisms of Action (Mediators) We expect that changes in the phase, amplitude, or the degree of synchronization of circadian rhythm measures over treatment may account for some of the observed effects of treatment. To test this hypothesis, changes during treatment of markers of four circadian body rhythms will be assessed: sleep/wakefulness, rest/activity, melatonin secretion, and core body temperature. Quality of Life We will determine if the two light therapies are effective for insomnia relative to Hygiene in terms of their impact on health-related quality of life. These hypotheses will be tested in a parallel groups design with three conditions: Hygiene, Hygiene and Morning Light, and Hygiene and Evening Light. Daily treatments will last three months and after the end of treatment patients will be followed on a once-a-month basis for a period of three months. This will ultimately include 90 treatment subjects aged >60 yrs (three groups of 30 each) with PSG recordings, actigraphy, self-reports, circadian rhythm measures, and genotyping on all subjects in each condition. This five-year proposal will ultimately include 90 treatment subjects aged >60 years (three groups of 30 each) with PSG recordings, actigraphy, self-reports, circadian rhythm measures, and genotyping on all subjects in each condition.