Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia
详细描述
In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild to moderate Alzheimer's disease and related dementia (ADRD)
排除标准
- •major organ failure,
- •major illness,
- •history of head injury,
- •hypertension or diabetes,
- •use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness
研究组 & 干预措施
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).
干预措施: High Active intervention (Other)
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).
干预措施: Inactive intervention (Other)
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).
干预措施: Mid Level Active Intervention (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Change from Baseline (week 0) and intervention (week 4)
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
Cohen-Mansfield Agitation Inventory (CMAI)
时间窗: Change from Baseline (week 0) and intervention (week 4)
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
Cornell Scale for Depression in Dementia (CSDD) Questionnaire
时间窗: Change from Baseline (week 0) and intervention (week 4)
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.
次要结局
- Activity of Daily Living Questionnaire (MDS-ADL)(Change from Baseline (week 0) and intervention (week 4))
- Circadian Stimulus Dose(Change from Baseline (week 0) and intervention (week 4))
- Sleep Efficiency Score(Change from Baseline (week 0) and intervention (week 4))
研究者
Mariana Figueiro
Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai