The Long-term Impact of a Light Intervention on Sleep Physiology and Cognition in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
研究概览
简要总结
To investigate the impact of a long-term light treatment intervention on sleep physiology and memory in mild cognitively impaired and mild Alzheimer's disease patients living at home. The goal is also to measure the impact of the lighting intervention on caregivers' sleep, cognition, depression, and quality of life.
详细描述
The current application proposes to investigate the impact of a long-term light treatment intervention on sleep physiology and sleep-dependent cognitive processes in mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) patients. The premise is that older adults, especially those with cognitive impairment, are often in continuous dim light, which leads to circadian misalignment. Circadian misalignment impacts the close relationship between homeostatic and circadian processes, which can reduce memory-related sleep features. The hypothesis is that a lighting intervention technology (LIT), designed to promote circadian entrainment, will improve sleep by aligning the two sleep processes (circadian and homeostatic) and, thus improve cognition. In addition to improving patients' lives, LIT has the potential to reduce the overnight burden on caregivers. Thus, an exploratory goal is to also measure the impact of LIT on caregivers' sleep, cognition, depression, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for MCI/Mild AD Participant:
- •Subject has diagnosis of amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD), as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 24 and those who fall between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) instrument
- •Subject has sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index and sleep efficiency below 80% as indicated via actigraphy
- •Subject resides in his/her home, independent living, or assisted living facilities with a caregiver.
排除标准
- •for MCI/Mild AD Participant:
- •Subject diagnosed with another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- •Subject resides in a skilled nursing facility or long-term care
- •Subject has had recent changes in psychotropics (14 days)
- •Subject has major organ failure (e.g., kidney failure)
- •Subject has uncontrolled generalized disorders such as hypertension or diabetes
- •Subject has obstructing cataracts, macular degeneration, and/or blindness
- •Subject has undergone cataract surgery and received an intraocular lens coated with ultraviolet- and blue-blocking filters (400-440/440-500 nm)
- •Subject diagnosed with severe sleep apnea; using the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ) the study will use a score of 29 as a cutoff for men and a cutoff of 26 for women
- •Subject diagnosed with restless leg syndrome (RLS); using the International Restless Legs Scale (IRLS), the study will use a cutoff of ≥11 as a positive screen for RLS
- •Subject has a history of severe photosensitivity dermatitis, severe progressive retinal disease (e.g., macular degeneration), or a permanently dilated pupil (e.g., after certain types of cataract surgery)
- •For caregivers, we will accept those who:
- •Live with the patients
- •Are not diagnosed with dementia (MOCA between 25 and 30 and CDR=0)
- •Understand English
- •Are willing to help with the study
- •No other inclusion/exclusion criteria will be used for enrolling caregivers. There is no age requirement for caregivers.
研究组 & 干预措施
Active Lighting intervention
The active lighting intervention will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. Combining spectrum and light level, the intervention will allow us to: (1) use a light source that will stimulate the circadian system and (2) provide the participants with options as to how the light treatment will be delivered
干预措施: Lighting Intervention (Device)
Control Lighting Intervention
The control lighting intervention will consist of low levels of a warm light source designed not to impact the circadian system.
干预措施: Lighting Intervention (Device)
结局指标
主要结局
Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
时间窗: Will be administered at baseline and the end of weeks 9, 17, 25 and 37
Change in cognition of the MCI participant will be assessed utilizing the Alzheimer's Disease Assessment Scale-Cognitive to capture subtler changes in cognitive performance. The ADAS-Cog is the most widely used general cognitive measure in clinical trials of Alzheimer's disease. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation.
Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
时间窗: Will be administered at baseline and the end of weeks 9, 17, 25 and 37
Change in cognition of the MCI participant will be assessed utilizing the Alzheimer's Disease Assessment Scale-Cognitive to capture subtler changes in cognitive performance. The ADAS-Cog is the most widely used general cognitive measure in clinical trials of Alzheimer's disease. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation.
次要结局
- Depression using the Geriatric Depression Scale (GDS)(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
- Quality of Life using the Dementia Quality of Life Instrument (DQoL)(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
- Light Exposure measurement in MCI Participants(Will be worn for seven days during baseline and seven days during weeks 9, 17, 25 and 37)
- Sleep Efficiency in the MCI Participant(Will be worn for seven days during baseline and for seven days during weeks 9, 17, 25 and 37)
- Cognition using the Montreal Cognitive Assessment (MoCA) tool(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
- Sleep Quality in the MCI Participant using the Pittsburgh Sleep Quality Index (PSQI)(Will be administered at baseline and the end of weeks 9, 17, 25 and 37)
研究者
Mariana Figueiro
Professor
Icahn School of Medicine at Mount Sinai