Methodology Issues in a Tailored Light Treatment for Persons with Dementia

项目总结/摘要 这项研究的主要假设是，提供一个昼夜有效的，定制的照明干预（TLI） 将揭示剂量（量和持续时间）与结局指标改善之间的强相关性 阿尔茨海默病（AD）和相关痴呆（ADRD）患者的睡眠、行为和情绪， 更大的反应与更大的剂量相关。还假设，较长的早晨TLI 暴露（例如，4小时）将更有效地改善这些结果，全天TLI暴露将 导致更晚的就寝时间和更长的睡眠开始潜伏期。进一步假设，长期暴露于 TLI将促进更好的睡眠，改善认知，减少抑郁和激动， 控制照明干预。正在进行的一项关于TLI提供固定量的 昼夜节律刺激（CS）已证明AD/ADRD患者的睡眠和行为有显著改善 患者，在短期（4周）和长期（4个月）。阐明了 TLI的剂量和研究结果将进一步促进对AD/ADRD的科学理解 同时为新的照明产品的开发提供了一个转换组件， 睡眠和减少AD/ADRD患者行为障碍。 该研究的目的有三个方面，涉及生活在受控环境中的AD/ADRD患者（记忆护理， 疗养院，长期护理），检查TLI对睡眠，行为和情绪测量的影响。一是 一项涉及135名受试者的随机、受试者内、安慰剂对照研究将研究 3次TLI给药，1小时/天，连续3个4周周期（中间有2次4周洗脱）。第二 一项涉及135名受试者的随机、混合设计、安慰剂对照研究将调查 固定CS TLI（与正在进行的研究相同），持续3次（早晨2小时、早晨4小时和全天） 连续2个4周周期（中间有1个4周洗脱期）。非主动照明干预将 用作3种活性TLI病症中每一种的安慰剂对照。第三项单组、安慰剂对照研究 涉及200名参与者，将研究最佳CS剂量（量和持续时间）的影响 从前两个目标确定）为期6个月。参加者将被随机挑选， 无论是积极的或安慰剂干预。对于所有3个研究目的，将在现场测量CS剂量。 这个项目的优势是相当大的，因为很少有其他工具可以测量 个人昼夜光照和活动模式。研究人群将受益匪浅， 立即从一个定制的，非药物治疗，以提高睡眠效率和巩固。 有效的治疗可以大大减轻社会负担，更直接地减轻照顾者的负担。专家 项目团队是独一无二的，包括一名执业医生/临床医生，他们可以接触到人群和一个团队。 研究人员在照明，照明技术，睡眠和昼夜节律的专业知识。

Project Summary/Abstract This study's principal hypothesis is that delivering a circadian-effective, tailored lighting intervention (TLI) will reveal a strong association between dose (amount and duration) and improvement in outcome measures of sleep, behavior, and mood among people with Alzheimer's disease (AD) and related dementias (ADRD), with greater responses being associated with greater doses. It is also hypothesized that a longer morning TLI exposure (e.g., 4 h) will be more effective for improving theses outcomes, and that an all-day TLI exposure will result in later bedtimes and greater sleep onset latency. It is further hypothesized that long-term exposure to the TLI will promote better sleep, improved cognition, and reduced depression and agitation compared to control lighting intervention. Preliminary results from an ongoing study of a TLI delivering a fixed amount of circadian stimulus (CS) have demonstrated significant improvements in sleep and behavior in AD/ADRD patients, over both the short (4 weeks) and the long (4 months) term. Elucidating the relationship between the TLI's dose and the study's outcomes will further contribute to the scientific understanding of AD/ADRD while providing a translational component for the development of new lighting products designed to promote sleep and reduce behavioral disturbances in AD/ADRD patients. The study's aims are 3-fold and involve AD/ADRD patients living in controlled environments (memory care, nursing homes, long-term care), examining the TLI's effects on measures of sleep, behavior, and mood. First, a randomized, within-subjects, placebo-controlled study involving 135 participants will investigate the effects of 3 TLI doses, 1 h/day, for 3 consecutive 4-week periods (with 2 intervening 4-week washouts). A second randomized, mixed design, placebo-controlled study involving 135 participants will investigate the effects of a fixed-CS TLI (same as in the ongoing study) of 3 durations (2 h in the morning, 4 h in the morning, and all day) for 2 consecutive 4-week periods (with 1 intervening 4-week washout). A non-active lighting intervention will be used as placebo control for each of the 3 active TLI conditions. A third single-arm, placebo-controlled study involving 200 participants will investigate the impact of the optimal CS dose (amount and duration determined from the first two aims) for a period of 6 months. Participants will be randomly selected to receive either the active or the placebo intervention. The CS dose will be measured in the field for all 3 study aims. The strengths of this project are considerable, as very few instruments are otherwise available to measure personal circadian light exposures and activity patterns. The study population would benefit immensely and immediately from a tailored, non-pharmacological treatment to improve sleep efficiency and consolidation. Effective treatment can significantly reduce the burden on society and, more directly, on caregivers. The expert project team is unique, including a practicing physician/clinician who has access to the population and a team of researchers with expertise in lighting, lighting technologies, sleep, and circadian rhythms.