Blue-White Light Therapy for Circadian Sleep Disorders in Alzheimer's Disease

蓝白光疗法治疗阿尔茨海默病的昼夜节律睡眠障碍

• 批准号: 7532523
• 负责人: PHILIP D SLOANE
• 金额: $ 29.72万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7532523
• 关键词: Address; Adverse effects; Adverse event; Affect; Alzheimer' s Disease; Anxiety; Area; Basic Science; Body Temperature; Caregiver Burden; Caregivers; Caring; Characteristics; Chronic Insomnia; Circadian Rhythms; Clinical Trials; Collaborations; Condition; Confusion; Data; Dementia; Disease; Distress; Dose; Effectiveness; Elderly; Eligibility Determination; Enrollment; Exhibits; Eye; Family Caregiver; Health; Health Expenditures; Health Services Research; Healthcare; Home environment; Hour; Impaired cognition; Individual; Institutionalization; Intervention; Intervention Studies; Jet Lag Syndrome; Learning; Life; Light; Lighting; Long-Term Care; Measures; Melatonin; Mental Depression; Mental Health; Methods; Movement; Numbers; Nursing Homes; Outcome; Participant; Patients; Pattern; Periodicity; Personal Satisfaction; Persons; Pharmaceutical Preparations; Phase II Clinical Trials; Photic Stimulation; Photobiology; Phototherapy; Placebos; Placement; Population; Prevalence; Protocols documentation; Public Health; Quality of life; Randomized Clinical Trials; Recruitment Activity; Reporting; Research; Risk; Safety; Scheme; Scientist; Seasonal Affective Disorder; Severities; Sleep; Sleep Disorders; Sleep Wake Cycle; Sleep disturbances; Source; Specific qualifier value; Statistically Significant; Symptoms; System; Task Performances; Techniques; Testing; Time; Visual; Week; Wrist; actigraphy; alertness; care giving burden; caregiving; clinically significant; cost; day; depressive symptoms; design; functional disability; gastrointestinal; immune function; improved; innovation; light treatment; medical specialties; meter; novel; shift work; size; sleep onset; study characteristics; systems research

DESCRIPTION (provided by applicant): Disturbed night-time sleep is common in older persons with Alzheimer's disease and related dementias (ADRD), leading to significant negative effects on the daytime function of the affected person and on the well-being of caregivers. Sedating drugs, the conventional treatment for disturbed sleep, have limited effectiveness and pose increased risk in this population. Disturbed sleep in ADRD is virtually always accompanied by marked disturbances of the circadian system, and research has established that controlled bright-dark light cycles will synchronize that system to the 24-hour solar day. Clinical trials of light therapy in unselected nursing home residents with ADRD have identified statistically significant but modest effects on sleep; however, most have used treatment systems that are inefficient and poorly tolerated. Taking advantage of recent findings from basic research on photobiology and the lessons learned from clinical trials to date, this phase 2 clinical trial will evaluate the efficacy, tolerability, and safety of a novel, refined method of delivering light as therapy to persons with ADRD who have disturbed sleep. Among the innovations in this method are: a) use of newly available, narrow band (peak ? = 460 nm) light sources that will provide greater circadian stimulation at lower levels of visual brightness; b) use of a novel delivery system that will allow the treatment to be applied to living spaces instead of requiring subjects to sit in front of light panels; c) restriction of the study to persons with ADRD who have disturbed sleep and do not have a primary sleep disorder requiring specialty care; and d) application to the home setting, with assessment of the impact of the intervention on family caregivers. The trial will enroll and study 18 persons, each of whom will receive 6 weeks of the intervention and 6 weeks of a low circadian-stimulating red light control condition. Primary outcomes will be sleep latency, duration and efficiency, measured by wrist actigraphy, and burden and caregiving hassles reported by family caregivers. The study will also determine the acceptability of the intervention to participants, the prevalence of potential adverse effects, and will measure, using a novel circadian light meter, the amount of circadian and visual stimulation achieved at participant eye level. The study team consists of an interdisciplinary group of scientists from a leading long-term care research center and a nationally-prominent lighting research center. The proposed lighting scheme is practical, does not restrict movement, and could be replicated at modest cost. Therefore, if the proposed preliminary study were successful and subsequent larger trials confirmatory, such a treatment could improve the health, well-being, and safety of several million elderly who have dementia and clinically significant circadian-related sleep disorders, and also benefit their caregivers. PUBLIC HEALTH RELEVANCE: Approximately five million persons in the U.S.A. currently suffer from Alzheimer's Disease and Related Disorders (ADRD), and that number is anticipated to grow to between 12 and 14 million by 2050. Sleep disturbances affect the majority, leading to further functional impairment and a risk of early institutionalization, as well as having negative impact on the mental health, sleep patterns, and physical health of family caregivers. Existing treatments are relatively ineffective and are associated with a high risk of adverse events. Therefore, improved treatment of sleep problems in persons with ADRD would improve health outcomes of both the person with the disease and of family caregiver, and has the potential to reduce overall health care expenditures and delay nursing home placement for this large and growing patient population.

描述（由申请人提供）：在阿尔茨海默氏病和相关痴呆症（ADRD）的老年人中，夜间睡眠不佳，导致对受影响人的白天功能以及照料者的福祉产生重大负面影响。镇静药物，常规的睡眠治疗方法，有效性有限，在该人群中的风险增加。 ADRD的干扰睡眠实际上总是伴随着昼夜节律系统的明显干扰，研究确定，控制的明亮黑暗的光周期将使该系统同步到24小时的太阳日。 ADRD未选择的疗养院居民的光治疗的临床试验已经确定了对睡眠的统计学意义但适度的影响；但是，大多数人使用的治疗系统效率低下且耐受性不佳。 利用了迄今为止从临床试验中学到的经验教训的最新研究结果，这一阶段2临床试验将评估一种新颖的，精致的方法，将光线作为治疗的疗效，可耐受性和安全性，以使睡眠困扰的ADRD患者提供光线治疗。在这种方法中，创新包括：a）使用新近可用的狭窄带（峰？= 460 nm）光源，这些光源将在较低的视觉亮度下提供更大的昼夜节律刺激； b）使用一种新型的输送系统，该系统将允许将治疗应用于生活空间，而不是要求受试者坐在轻板前； c）将研究限制给患有障碍睡眠且没有需要专业护理的初级睡眠障碍的ADRD患者； d）通过评估干预对家庭护理人员的影响，适用于家庭环境。该试验将注册并研究1​​8人，每个人将接受干预的6周和6周的低昼夜节律刺激红光控制条件。主要结果将是通过腕部行为衡量的睡眠潜伏期，持续时间和效率，以及家庭护理人员报告的负担和照料麻烦。该研究还将确定参与者干预的可接受性，潜在的不良反应的流行，并使用新型的昼夜节律计量，在参与者眼睛水平上实现的昼夜节律和视觉刺激的量。研究团队由一个领先的长期护理研究中心和全国性的照明研究中心的跨学科科学家组成。 拟议的照明方案是实用的，不限制运动，并且可以以适中的成本进行复制。因此，如果拟议的初步研究成功并随后进行了更大的试验确认性，则这种治疗可以改善具有痴呆症和临床上与昼夜节律相关的几百万老年人的健康，福祉和安全性，也可以使他们的照料者受益。 公共卫生相关性：美国目前约有500万人患有阿尔茨海默氏病和相关疾病（ADRD），到2050年到2050年，这一数字预计将增长到12至1400万之间。睡眠障碍会影响大多数人，导致进一步的功能障碍，导致进一步的功能障碍和对早期机构化的风险以及对精神健康的影响，以及对精神健康的影响，以及身体健康，身体健康，家庭护理和家庭护理。现有治疗相对无效，并且与不良事件的高风险有关。因此，改善ADRD患者的睡眠问题的治疗将改善患有该疾病和家庭护理人员的人的健康状况，并有可能减少整体医疗保健支出并延迟这个大型且不断增长的患者人群的养老院安置。