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: 10320581
• 负责人: Mariana Gross Figueiro
• 金额: $ 82.88万
• 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/10320581
• 关键词: Address; Affect; Agitation; Alzheimer' s Disease; Alzheimer' s disease related dementia; Assisted Living Facilities; Behavior; Behavioral; Caregivers; Circadian Rhythms; Cognition; Controlled Environment; Data; Data Collection; Dementia; Development; Devices; Dose; Elderly; Enrollment; Exposure to; Family; Family Caregiver; Fatigue; Grant; Home; Home environment; Intervention; Lead; 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; Randomized; Records; Research Personnel; Rest; Sleep; Sleep disturbances; Societies; Stimulus; Stress; Study Section; Symptoms; System; Technology; Testing; Visual; Wakefulness; arm; awake; circadian; design; effective therapy; experience; improved; instrument; intervention effect; loved ones; memory care; placebo controlled study; portability; response; sleep abnormalities; sleep behavior; 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.

项目摘要/摘要 这项研究的主要假设是提供昼夜节律量身定制的照明干预（TLI） 将揭示剂量（数量和持续时间）之间的牢固关联和结果指标的改善 阿尔茨海默氏病（AD）和相关痴呆症患者的睡眠，行为和情绪 随着更多的反应与更大的剂量有关。还假设一个更长的早晨TLI 暴露（例如4小时）将更有效地改善这些结果，并且全天的TLI暴露将会 导致后期的睡眠时间和更大的睡眠发作潜伏期。进一步假设长期接触 与 控制照明干预。对TLI的持续研究的初步结果 昼夜节律刺激（CS）在AD/ADRD的睡眠和行为上表现出显着改善 在短期（4周）和长期（4个月）期内的患者。阐明 TLI的剂量和研究的结果将进一步有助于对AD/ADRD的科学理解 同时为开发旨在促进的新照明产品的开发提供了翻译成分 睡眠并减少AD/ADRD患者的行为障碍。 该研究的目的是3倍，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，行为和情绪措施的影响。首先，a 随机，受试者内的安慰剂对照研究涉及135名参与者 3个TLI剂量，1小时/天，连续3个周期（有2个介入4周的洗衣服）。第二 涉及135名参与者的随机，混合设计，安慰剂控制的研究将研究 固定-CS TLI（与正在进行的研究中的固定CS TLI（早上2小时，早晨4小时，全天） 连续2个4周期间（有1个介入4周的洗涤）。非活动的照明干预将 用作3个活动TLI条件中的每个条件中的每一个。第三臂，安慰剂控制的研究 涉及200名参与者将研究最佳CS剂量的影响（量和持续时间 从前两个目标确定）持续6个月。参与者将随机选择接收 主动或安慰剂干预。 CS剂量将在所有3个研究目的的现场测量。 该项目的优势是相当大的，因为否则很少有乐器可以衡量 个人昼夜节律暴露和活动模式。研究人群将极大地受益，并且 立即从量身定制的非药物治疗来提高睡眠效率和巩固。 有效的治疗可以显着减轻社会的负担，更直接地减轻照料者的负担。专家 项目团队独特 具有照明，照明技术，睡眠和昼夜节律方面的专业知识的研究人员。