为痴呆症患者量身定制光疗的方法学问题
2026年6月29日 更新者：Mariana Figueiro、Icahn School of Medicine at Mount Sinai
为痴呆症患者量身定制光疗的第一阶段方法学问题
量身定制的光治疗将提高阿尔茨海默病和相关痴呆症患者的睡眠效率，减少抑郁症并降低躁动评分
研究概览
地位
完全的
详细说明
在受试者内部随机安慰剂对照研究中，将使用定制的短期（4 周）光治疗。
结果测量包括睡眠测量（体动记录仪）以及调查被诊断患有阿尔茨海默病和相关痴呆症的人的行为和情绪的问卷。
经过 4 周的清除期后，将再使用安慰剂对照非活动光 4 周。
研究类型
介入性
注册 (实际的)
44
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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Albany、New York、美国、12204
- Icahn School of Medicine at Mount Sinai
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
是的
描述
纳入标准：
- 轻度至中度阿尔茨海默病和相关痴呆症 (ADRD)
排除标准：
- 主要器官衰竭，
- 重大疾病，
- 头部外伤史，
- 高血压或糖尿病，
- 使用精神药物（睡眠辅助药物）、阻塞性白内障、黄斑变性和失明
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Participants with Dementia
All participants experience a baseline for 1 week and an active intervention for 4 weeks for all 3 conditions (high active intervention, mid level active intervention, and inactive intervention).
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The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
The Mid level active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI)
大体时间：Change from Baseline (week 0) and intervention (week 4)
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Caregivers (on behalf of subjects who cannot complete) and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention.
The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance.
A higher number indications a greater sleep disturbance
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Change from Baseline (week 0) and intervention (week 4)
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Cohen-Mansfield Agitation Inventory (CMAI)
大体时间：Change from Baseline (week 0) and intervention (week 4)
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Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out the Cohen-Mansfield Agitation Score, which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention.
29 item instrument, each item scored 1-7.
Total range score from 29-203 - a higher score indicates more agitation
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Change from Baseline (week 0) and intervention (week 4)
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Cornell Scale for Depression in Dementia (CSDD) Questionnaire
大体时间：Change from Baseline (week 0) and intervention (week 4)
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Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective questionnaires assessing depression using the Cornell Scale for Depression in Dementia (CSDD) Questionnaires are assessed at baseline and after 4 weeks they are exposed to the lighting intervention.
The CSDD consists of 19 questions rated on a scale of 0 to 2 with all scores summed for a total score range 0-38.
A score greater than 12 indicates depression and a higher score indicates greater depression.
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Change from Baseline (week 0) and intervention (week 4)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Activity of Daily Living Questionnaire (MDS-ADL)
大体时间：Change from Baseline (week 0) and intervention (week 4)
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Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective Activity of Daily Living questionnaire (MDS-ADL), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention.
Scores range from 4 to 18 and a higher score indicates a higher dependence.
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Change from Baseline (week 0) and intervention (week 4)
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Circadian Stimulus Dose
大体时间：Change from Baseline (week 0) and intervention (week 4)
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Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied.
These data are used to determine circadian disruption (correlation between light/dark and activity/rest) and light dose.
Circadian stimulus (CS) is the amount of light needed to activate the circadian system.
The range is 0 to 0.6 the higher the number the greater the CS dose
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Change from Baseline (week 0) and intervention (week 4)
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Sleep Efficiency Score
大体时间：Change from Baseline (week 0) and intervention (week 4)
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Subjects are asked to wear an actigraph to obtain activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied.
Actigraphs are used to measure sleep efficiency.
Full scale score from 0-100, higher score indicates better efficiency.
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Change from Baseline (week 0) and intervention (week 4)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mariana G Figueiro, PhD、Icahn School of Medicine at Mount Sinai
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Hanford N, Figueiro M. Light therapy and Alzheimer's disease and related dementia: past, present, and future. J Alzheimers Dis. 2013;33(4):913-22. doi: 10.3233/JAD-2012-121645.
- Figueiro MG, Hamner R, Higgins P, Hornick T, Rea MS. Field measurements of light exposures and circadian disruption in two populations of older adults. J Alzheimers Dis. 2012;31(4):711-5. doi: 10.3233/JAD-2012-120484.
- Figueiro MG, Plitnick BA, Lok A, Jones GE, Higgins P, Hornick TR, Rea MS. Tailored lighting intervention improves measures of sleep, depression, and agitation in persons with Alzheimer's disease and related dementia living in long-term care facilities. Clin Interv Aging. 2014 Sep 12;9:1527-37. doi: 10.2147/CIA.S68557. eCollection 2014.
- Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年1月1日
初级完成 (实际的)
2024年5月10日
研究完成 (实际的)
2024年5月10日
研究注册日期
首次提交
2013年3月15日
首先提交符合 QC 标准的
2013年3月21日
首次发布 (估计的)
2013年3月22日
研究记录更新
最后更新发布 (实际的)
2026年7月27日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.