Improving Sleep In Nursing Homes

描述(申请人提供)：养老院居民失眠的发生率很高。失眠可能导致白天昏昏欲睡，在床上和睡觉的时间过长，参与活动减少，抑郁和其他行为症状，摔倒风险增加和生活质量下降。美国国立卫生研究院最近召开的一次共识会议强调，有必要解决养老院居民等特殊人群的失眠问题，并调查各种干预措施的有效性，无论是单独干预还是联合干预。我们最近在8家亚特兰大疗养院的160名居民中完成了一项非药物睡眠卫生干预(SHI)的对照临床试验。石人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，以检验雷美尔顿(一种最近获得批准的催眠药，作为褪黑素受体激动剂)与改良的SHI联合使用在对SHI无效的疗养院居民中的疗效。经过仔细的筛查和临床评估，符合条件的受试者将接受基线测量，然后接受为期3周的SHI。单独对SHI无效的受试者将被随机分成两组，分别接受每晚8毫克的雷美尔顿治疗或与SHI相匹配的安慰剂治疗2周。主要的结果衡量标准将是活动记录仪测量的睡眠效率。多导睡眠图也将在一组受试者中进行。次要临床结果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，与服用安慰剂的受试者相比，接受雷美尔顿和SHI联合治疗的受试者夜间睡眠效率将显著提高。我们还假设，与接受安慰剂治疗的受试者相比，接受Ramelteon治疗的患者在白天睡眠、卧床时间、参与活动和情绪方面的指标将发生积极变化，并且这些改善将与夜间睡眠效率的提高呈正相关。基于我们之前的研究和其他人的研究，我们认为这项研究是改善对一种严重影响这一人群生活质量的流行和病态疾病的管理的关键下一步。

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.