Methodology Issues in a Tailored Light Treatment for Persons with Dementia

为痴呆症患者量身定制光疗的方法学问题

• 批准号: 10570263
• 负责人: Mariana Gross Figueiro
• 金额: $ 78.23万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-15 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10570263
• 关键词: Address; Affect; Agitation; Alzheimer' s Disease; Alzheimer' s disease related dementia; Assisted Living Facilities; Behavior; Behavioral; Calibration; Caregivers; Circadian Rhythms; Cognition; Controlled Environment; Darkness; Data; Data Collection; Dementia; Development; Devices; Dose; Elderly; Enrollment; Exposure to; Family; Family Caregiver; Fatigue; Grant; Home; Home environment; Institution; Intervention; Light; Lighting; Long-Term Care; Measurement; Measures; Memory; Mental Depression; Methodology; Moods; Multi-Institutional Clinical Trial; Nursing Homes; Outcome; Outcome Measure; Outcome Study; Participant; Patients; Pattern; Persons; Phase; Phototherapy; Physicians; Placebo Control; Placebos; Population; Precipitating Factors; Protocols documentation; Quality of life; Random Allocation; Randomized; Records; Research Personnel; Rest; Sleep; Sleep disturbances; Societies; Stimulus; Stress; Study Section; Symptoms; System; Technology; Testing; Visual; Wakefulness; arm; awake; circadian; comparison control; design; effective therapy; experience; improved; improvement on sleep; instrument; intervention effect; loved ones; memory care; placebo controlled study; portability; response; sleep abnormalities; sleep onset; sleep quality; study population

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.

项目概要/摘要 这项研究的主要假设是提供昼夜节律有效的、量身定制的照明干预 (TLI) 将揭示剂量（数量和持续时间）与结果指标改善之间的密切关联 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。还假设早晨 TLI 较长 暴露（例如 4 小时）将更有效地改善这些结果，并且全天 TLI 暴露将 导致就寝时间较晚，入睡潜伏期较长。进一步假设，长期暴露于 与相比，TLI 将促进更好的睡眠、改善认知、减少抑郁和躁动 控制照明干预。一项正在进行的 TLI 提供固定数量的研究的初步结果 昼夜节律刺激 (CS) 已证明 AD/ADRD 患者的睡眠和行为有显着改善 短期（4 周）和长期（4 个月）的患者。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转化组件，旨在促进 睡眠并减少 AD/ADRD 患者的行为障碍。 该研究有 3 个目标，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 剂量，1 小时/天，连续 3 个 4 周周期（中间有 2 个 4 周清除期）。一秒钟 涉及 135 名参与者的随机、混合设计、安慰剂对照研究将调查 3 个持续时间的固定 CS TLI（与正在进行的研究相同）（早上 2 小时、早上 4 小时和全天） 连续 2 个 4 周周期（中间有 1 个 4 周冲洗期）。非主动照明干预将 用作 3 种活跃 TLI 条件中每一种的安慰剂对照。第三项单臂安慰剂对照研究 涉及 200 名参与者的研究将调查最佳 CS 剂量（剂量和持续时间）的影响 根据前两个目标确定），为期 6 个月。参与者将被随机选择以接收 积极干预或安慰剂干预。将在现场测量所有 3 个研究目标的 CS 剂量。 该项目的优势是相当大的，因为很少有仪器可以用来测量 个人昼夜节律光照和活动模式。研究人群将受益匪浅 立即进行量身定制的非药物治疗，以提高睡眠效率和巩固睡眠。 有效的治疗可以显着减轻社会的负担，更直接地减轻护理人员的负担。专家 项目团队是独一无二的，包括一名能够接触到人群的执业医师/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。