Behavioral Treatment of Nocturnal Disturbances in AD

描述（由申请人提供）：夜间障碍，如徘徊，昼夜混乱，反复下床，从事不适当的活动，幻觉，在床上说话或唱歌，以及神志不清在阿尔茨海默病（AD）患者中非常常见。夜间被叫醒已被确定为痴呆症护理中最令人不安的方面之一。它与患者和护理人员的生理和心理发病率增加有关，是患者住院的主要危险因素。尽管事实上超过70%的痴呆患者住在家里，并由家人和朋友照顾，但只有一项针对社区居住AD患者夜间障碍的对照行为治疗研究（阿尔茨海默病夜间失眠治疗和教育，或NITE-AD研究）。该研究是由当前应用程序的私家侦探进行的试点研究，结果显著减少了患者夜间醒来的次数和夜间清醒的总时间。最近，美国国立卫生研究院的一个工作组提出了一套阿尔茨海默病患者睡眠/觉醒周期障碍的诊断标准，并呼吁研究开发和评估这些障碍的非药物治疗方法。拟议的研究是对这一呼吁的回应。本研究是一项随机对照试验，旨在评估步行(W)、光照(L)以及联合步行、光照和睡眠卫生建议（NITE-AD）与常规医疗教育（RE）相比减少社区AD患者夜间干扰的疗效。200名符合阿尔茨海默病患者睡眠/觉醒周期障碍标准并与家庭照顾者一起生活的患者将从全州阿尔茨海默病患者社区网络中招募。患者和护理者的治疗效果将在基线、1个月、2个月和6个月的随访中进行评估。病人住院率将监测一年。主要结果将是患者夜间总清醒时间的活动测量，以及护理人员对患者夜间行为障碍的报告。次要结局包括护理者睡眠、患者日间嗜睡和总体行为问题水平、患者和护理者的情绪和健康状况以及患者居住状况。

DESCRIPTION (provided by applicant): Nocturnal disturbances such as wandering, day/night confusion, getting out of bed repeatedly, engaging in inappropriate activities, hallucinations, talking or singing in bed, and increased confusion are very common in persons with Alzheimer's disease (AD). Being awakened at night has been identified as one of the most disturbing aspects of dementia caregiving. It is associated with increased physical and psychological morbidity in both patients and caregivers, and is a major risk factor for patient institutionalization. Despite the fact that over 70% of demented individuals live at home and are cared for by family and friends, there has been only one controlled behavioral treatment study targeting nocturnal disturbances in community-dwelling AD patients (the Nighttime Insomnia Treatment and Education for Alzheimer's Disease, or NITE-AD study). That study, a pilot conducted by the P.I. of the current application, produced significant reductions in number of patient nighttime awakenings and total time awake at night. A recent NIH task force proposed a set of diagnostic criteria for sleep/wake cycle disturbances in AD patients, and called for research to develop and evaluate non-pharmacological treatments for these disturbances. The proposed study is a response to this call. This study is a randomized controlled trial to evaluate the efficacy of Walking (W), Light Exposure (L), and combined walking, light exposure, and sleep hygiene recommendations (NITE-AD) to reduce nocturnal disturbances in community-dwelling AD patients, compared to Routine Medical Care with Education (RE). Two hundred patients that meet criteria for sleep/wake cycle disturbances in AD and live with a family caregiver will be recruited from a statewide community network of AD patients. Patient and caregiver treatment effects will be assessed at baseline, 1 month, 2 months, and 6-month follow-up. Patient institutionalization rates will be monitored for one year. The primary outcomes will be actigraphic measures of patient total wake time at night, and caregiver reports of patient nighttime behavioral disturbances. Secondary outcomes include caregiver sleep, patient daytime sleepiness and overall level of behavior problems, patient and caregiver mood and health, and patient residential status.