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. ? ? ?
