TREATMENTS FOR INSOMNIA

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。关于强光治疗失眠的文献存在许多空白：1)它还没有在足够多的受试者中进行研究，以充分了解它对改善基本睡眠指标的功效，包括通过活动描记仪和多导睡眠描记仪（PSG）获得的数据；2)一天中提供治疗的最佳时间问题尚未解决；3)我们不知道治疗效果持续多久；4)我们不知道某些受试者的治疗效果是否比其他受试者更好；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，它是否也影响生活质量指标还不得而知。我们计划通过测试以下假设来解决这些差距：功效我们计划评估三种非药物治疗老年人失眠的短期和长期疗效：1)一种行为治疗，采用睡眠卫生的基本原则来改善睡眠和定时暴露在强光下，以及睡眠卫生原则；2)早晨发出的光，或者；3)晚上发出的光。我们假设，与单独使用卫生措施相比，明亮的光疗与卫生措施相结合会产生显著的附加效应。主要结局指标为总睡眠时间、睡眠开始后的清醒情况以及活动记录仪记录的睡眠效率。我们期望这些结果不仅在3个月的治疗期结束时出现，而且在3个月的随访中也会出现。反应的个体差异（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，两种卫生和光治疗的疗效将存在个体差异。这一建议为我们提供了初步检查昼夜节律标记和CLOCK基因等位基因状态预测失眠患者治疗反应的能力的机会。作用机制（介质）我们期望在治疗过程中昼夜节律测量的相位、幅度或同步程度的变化可以解释一些观察到的治疗效果。为了验证这一假设，研究人员将评估治疗过程中四种昼夜节律指标的变化：睡眠/清醒、休息/活动、褪黑激素分泌和核心体温。我们将根据对健康相关生活质量的影响来确定这两种光疗法对与卫生相关的失眠是否有效。这些假设将在三个条件下的平行组设计中进行测试：卫生，卫生和早晨的光线，卫生和晚上的光线。每日治疗将持续三个月，治疗结束后，患者将每月接受一次随访，为期三个月。最终将包括90名年龄在50 - 60岁之间的治疗受试者（三组，每组30人），对每种情况下的所有受试者进行PSG记录、活动记录仪、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名年龄在60岁至60岁之间的治疗受试者（每组30人），并对每种情况下的所有受试者进行PSG记录、活动记录仪、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.