Improving Sleep In Nursing Homes

改善疗养院的睡眠

• 批准号: 7482416
• 负责人: Patricia C. Griffiths
• 金额: $ 56.52万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7482416
• 关键词: Address; Adult; Affect; Agonist; Appendix; Area; Beds; Behavioral; Behavioral Symptoms; Chronic; Chronic Insomnia; Clinical; Clinical assessments; Condition; Consensus; Controlled Clinical Trials; Data; Drowsiness; Guidelines; High Prevalence; Hygiene; Injury; Intervention; Maintenance; Measurement; Measures; Melatonin Receptors; Moods; Nursing Homes; Outcome; Outcome Measure; Patients; Pharmaceutical Preparations; Placebos; Polysomnography; Population; Problem behavior; Quality of life; Randomized; Reporting; Research; Research Personnel; Risk; Role; Screening procedure; Sleep; Sleeplessness; Subgroup; Time; United States National Institutes of Health; Week; actigraphy; awake; base; day; depressive symptoms; double-blind placebo controlled trial; falls; hypnotic; improved; named group; programs; symposium

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.

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、在床上和睡眠时间过长、活动参与减少、抑郁和其他行为症状、跌倒风险增加/以及生活质量差。最近的美国国立卫生研究院共识会议强调，需要解决疗养院居民等特殊人群的失眠问题，并研究各种单独或联合干预措施的效果。我们最近在亚特兰大 8 家疗养院的 160 名居民中完成了一项非药物睡眠卫生干预 (SHI) 对照临床试验。 SHI 改善了大多数人的白天睡眠和床上时间，但对夜间睡眠没有影响。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，该试验将检查雷美替胺（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，对仅对 SHI 没有反应的疗养院居民的疗效。经过仔细筛选和临床评估后，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。仅对 SHI 没有反应的受试者将随机接受每晚 8 毫克雷美替胺或与 SHI 相匹配的安慰剂，持续两周。主要结果指标是通过体动记录仪测量的睡眠效率。还将对一组受试者进行多导睡眠监测。次要临床结果将包括夜间睡眠质量、日间睡眠、日间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，接受雷美替胺联合 SHI 治疗的受试者夜间睡眠效率将显着提高。我们还假设，与接受安慰剂治疗的受试者相比，接受雷美替胺治疗的受试者在日间睡眠、卧床时间、活动参与度和情绪方面将出现积极变化，并且这些改善将与夜间睡眠效率的提高呈正相关。根据我们之前和其他人的研究，我们相信这项研究是改善对深刻影响该人群生活质量的流行病态的管理的关键下一步。