Behavioral Treatment of Nocturnal Disturbances in AD

描述(申请人提供)：阿尔茨海默病(AD)患者的夜间障碍非常常见，如走神、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，以及意识障碍增加。夜间被叫醒已被认为是照顾痴呆症最令人不安的方面之一。它与患者和照顾者的生理和心理发病率增加有关，是患者住院的主要风险因素。尽管70%以上的痴呆症患者住在家里并得到家人和朋友的照顾，但只有一项针对社区居住的AD患者夜间干扰的受控行为治疗研究(夜间失眠治疗和阿尔茨海默病教育研究，或NITE-AD研究)。这项研究是由当前应用的P.I.进行的一项试点研究，显著减少了患者夜间醒来的次数和夜间醒来的总时间。NIH最近的一个工作组提出了一套AD患者睡眠/清醒周期障碍的诊断标准，并呼吁开展研究，开发和评估针对这些障碍的非药物治疗。这项拟议的研究正是对这一呼吁的回应。这项研究是一项随机对照试验，旨在评估步行(W)、光照(L)和联合步行、光照和睡眠卫生建议(NITE-AD)与常规教育医疗(RE)相比减少社区居住的AD患者夜间干扰的有效性。符合AD睡眠/觉醒周期障碍标准的200名患者将从全州AD患者社区网络中招募，并与家庭照顾者生活在一起。患者和护理者的治疗效果将在基线、1个月、2个月和6个月的随访时进行评估。病人住院率将进行为期一年的监测。主要结果将是对患者夜间总清醒时间的活动测量，以及患者夜间行为障碍的照顾者报告。次要结果包括护理者睡眠、患者日间困倦和行为问题的总体水平、患者和护理者的情绪和健康，以及患者的居住状况。

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.