Improving Sleep In Nursing Homes

描述（由申请人提供）：疗养院居民失眠的患病率很高。失眠可能会导致白天嗜睡，在床上和睡眠中花费的时间过多，活动参与减少，抑郁和其他行为症状，跌倒风险增加和生活质量差。最近的一次NIH共识会议强调，需要解决特殊人群（如疗养院居民）的失眠问题，并调查各种干预措施（单独和联合）的疗效。我们最近完成了一项对照临床试验的非药物睡眠卫生干预（SHI）在160名居民的8亚特兰大疗养院。SHI改善了白天的睡眠和卧床时间，但对大多数人的夜间睡眠没有影响。我们现在建议在这项研究的基础上，进行一项随机、双盲、安慰剂对照试验，检查雷美替恩的疗效，雷美替恩是一种最近批准的催眠药，可作为褪黑激素受体激动剂，与改良的SHI联合使用，在对SHI没有反应的疗养院居民中进行。在仔细筛选和临床评估后，合格受试者将接受基线测量，然后接受3周SHI。对单独SHI无应答的受试者将随机接受雷美替酮8 mg/晚或匹配安慰剂与SHI再治疗2周。主要结果测量将是通过体动记录仪测量的睡眠效率。还将在一个受试者亚组中进行多导睡眠描记术。次要临床结局将包括夜间睡眠质量、白天睡眠、白天活动和情绪的其他几个客观指标。我们假设，与接受安慰剂和SHI治疗的受试者相比，接受雷美替恩联合SHI治疗的受试者夜间睡眠效率将显著增加。我们还假设，与接受安慰剂治疗的受试者相比，接受雷美替恩治疗的受试者在白天睡眠、床上时间、活动参与度和情绪方面的测量值会发生积极变化，并且这些改善与夜间睡眠效率的增加呈正相关。根据我们以前的研究和其他人的研究，我们相信这项研究是改善对这种普遍和病态疾病的管理的关键下一步，这种疾病深刻影响了这一人群的生活质量。

DESCRIPTION (provided by applicant): Nursing home residents have a high prevalence of insomnia. Insomnia may contribute to daytime drowsiness with excessive time spent in bed and asleep, decreased participation in activities, depressive and other behavioral symptoms, increased fall risk/and poor quality of life. A recent NIH Consensus Conference emphasized the need to address insomnia in special populations such as nursing home residents, and to investigate the efficacy of various interventions, alone and in combination. We recently completed a controlled clinical trial of a non-pharmacological sleep hygiene intervention (SHI) in 160 residents of 8 Atlanta nursing homes. The SHI improved daytime sleep and time in bed, but had no effect on nighttime sleep in the majority of this population. We now propose to build on this research by conducting a randomized, double-blind, placebo-controlled trial that will examine the efficacy of ramelteon, a recently approved hypnotic that acts as a melatonin receptor agonist, in combination with a modified SHI, among nursing home residents who do not respond to the SHI alone. After careful screening and clinical assessments, eligible subjects will undergo baseline measurements and then receive the SHI for 3 weeks. Subjects who do not respond to the SHI alone will be randomized to receive either ramelteon 8 mg per night or matching placebo with the SHI for an additional 2 weeks. The primary outcome measure will be sleep efficiency measured by actigraphy. Polysomnography will also be performed in a subgroup of subjects. Secondary clinical outcomes will include several other objective measures of nighttime sleep quality, daytime sleep, daytime activity, and mood. We hypothesize that subjects treated with ramelteon combined with the SHI will have a significant increase in nighttime sleep efficiency compared to those who receive placebo with the SHI. We also hypothesize that those who receive ramelteon will have positive changes in measures of daytime sleep, time in bed, engagement in activities, and mood compared to subjects treated with placebo, and that these improvements will be positively correlated with increases in nightime sleep efficiency. Based on our previous research and that of others, we believe this study is a critical next step to improve the management of a prevalent and morbid condition that profoundly affects the quality of life of this population.