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: 7690272
• 负责人: PHILIP D SLOANE
• 金额: $ 28.89万
• 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 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7690272
• 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; Confusion; Data; Dementia; Disease; Distress; Dose; Effectiveness; Elderly; Eligibility Determination; Enrollment; Exhibits; Eye; Family Caregiver; Health; Health Expenditures; Health Services Research; Home environment; Hour; Impaired cognition; Individual; Institutionalization; Intervention; Intervention Studies; Jet Lag Syndrome; Learning; Life; Light; Lighting; Long-Term Care; Measures; Melatonin; Mental Health; Methods; Movement; Nursing Homes; Outcome; Participant; Pattern; Periodicity; Personal Satisfaction; Persons; Pharmaceutical Preparations; Phase II Clinical Trials; Photic Stimulation; Photobiology; Phototherapy; Placebos; Population; Prevalence; Protocols documentation; 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; Symptoms; System; Task Performances; Techniques; Testing; Time; Visual; Wrist; actigraphy; alertness; alternative treatment; care giving burden; caregiving; clinically significant; common treatment; conventional therapy; cost; depression; depressive symptoms; design; functional disability; gastrointestinal; high risk; immune function; improved; innovation; light treatment; medical specialties; meter; novel; patient population; physical conditioning; primary outcome; public health relevance; secondary outcome; shift work; 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）：夜间睡眠紊乱在患有阿尔茨海默病和相关痴呆（ADRD）的老年人中很常见，对患者的白天功能和护理人员的健康造成了显著的负面影响。镇静药物是治疗睡眠障碍的常规方法，但效果有限，而且对这一人群的风险增加。ADRD患者的睡眠紊乱实际上总是伴随着昼夜节律系统的明显紊乱，研究已经证实，受控的明暗光循环将使该系统与24小时的太阳日同步。在未选定的患有ADRD的养老院居民中进行的光疗临床试验已经确定了统计上显著但适度的对睡眠的影响；然而，大多数使用的治疗系统效率低下且耐受性差。

项目成果

Effect of home-based light treatment on persons with dementia and their caregivers.

• DOI: 10.1177/1477153513517255
• 发表时间: 2015-04
• 期刊: Lighting research & technology (London, England : 2001)
• 作者: Sloane PD;Figueiro M;Garg S;Cohen LW;Reed D;Williams CS;Preisser J;Zimmerman S
• 通讯作者: Zimmerman S