Methodology Issues in a Tailored Light Treatment for Persons with Dementia

项目摘要/摘要 这项研究的主要假设是提供昼夜有效的量身定制的照明干预(TLI) 将揭示剂量(剂量和持续时间)与结果衡量标准的改善之间的强烈关联 阿尔茨海默病(AD)和相关痴呆症(ADRD)患者的睡眠、行为和情绪， 更大的反应与更大的剂量相关。它还假设较长的上午TLI 暴露(例如，4小时)将更有效地改善这些结果，而全天TLI暴露将 导致更晚的就寝时间和更长的入睡潜伏期。它进一步假设，长期暴露于 TLI将促进更好的睡眠，改善认知，并减少抑郁和焦虑 控制照明干预。正在进行的TLI研究的初步结果，该研究提供了固定数量的 昼夜节律刺激(CS)显示AD/ADRD患者的睡眠和行为有显著改善 患者，短期(4周)和长期(4个月)。阐明两者之间的关系 TLI的剂量和研究结果将进一步有助于对AD/ADRD的科学理解 同时为新照明产品的开发提供翻译组件，旨在促进 睡眠和减少AD/ADRD患者的行为障碍。 这项研究的目标有三个方面，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、行为和情绪指标的影响。首先，一个 涉及135名参与者的随机、受试者内、安慰剂对照研究将调查 3次TLI，每天1小时，连续3次，共4周(其中2次间隔4周)。一秒钟 一项涉及135名参与者的随机、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)，持续时间为3个小时(早上2小时、早上4小时和全天) 连续2个为期4周的疗程(其中1个介入为期4周的冲洗)。非活动照明干预将 作为3种活跃的TLI条件下的安慰剂对照。第三项单臂安慰剂对照研究 200名参与者将调查最佳CS剂量(量和持续时间)的影响 根据前两个目标确定)，为期6个月。参赛者将被随机挑选接受 无论是积极干预还是安慰剂干预。CS剂量将在所有3个研究目标的现场测量。 这个项目的优势是相当大的，因为几乎没有其他可用来测量的仪器。 个人昼夜节律光暴露和活动模式。研究人群将受益匪浅， 立即从量身定做的非药物治疗，以提高睡眠效率和巩固。 有效的治疗可以显著减轻社会的负担，更直接地减轻照顾者的负担。专家 项目团队是独一无二的，包括一名可以接触到公众的执业医生/临床医生和一个团队 拥有照明、照明技术、睡眠和昼夜节律方面专业知识的研究人员。

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.