Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Metabolic control
研究概览
简要总结
To test the long term effect of a light treatment on cognition, sleep and metabolism in patients with Mild cognitive impairment (MCI) or mild Alzheimer's disease or related dementia (ADRD).
详细描述
Test if a tailored light intervention (TLI) that promotes entrainment can improve sleep disturbances, inflammation, insulin sensitivity (Si) and glucose disposal (Sg) and cognition in patients with MCI and mild ADRD and sleep disturbances. Using a single-arm, between-subjects, placebo-controlled study the investigators will investigate if long-term (6-month) exposure to TLI improves glucose homeostasis and insulin sensitivity in patients with MCI and mild AD who suffer from sleep disturbance and are living at home. Participants will be recruited from the Mount Sinai AD research center (ADRC) and randomized to receive the TLI (or comparison control treatment) at home. The investigators hypothesize that, compared to the comparison light, a TLI will increase entrainment, improve sleep, reduce depression, reduce inflammation, improve metabolic control, increase insulin sensitivity, and reduce susceptibility to T2DM and metabolic disease during and after the completion of the 6-month intervention.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild cognitive impairment
- •Mild Alzheimer's Disease
- •Sleep Disturbance
- •Live at home
排除标准
- •Blindness
- •insulin-dependent diabetes patients
- •macular degeneration
- •severe sleep apnea
研究组 & 干预措施
Active Lighting Intervention
The TLI 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, TLI will allow us to: (a) use a light source that will stimulate the circadian system, and (b) provide the participants with options as to how the light treatment will be delivered. The investigators will deliver at least 300-400 lux at the eye of the bluish-white light during the day (CS of 0.4 or greater).
The lighting intervention will be in place for 24 weeks
干预措施: Tailored Lighting Intervention (Device)
Placebo Lighting Intervention
The placebo condition light source will be a warm yellow - white (2700 - 3000 K) source providing 50 -100 lux at the eye. The lighting intervention will be in place for 24 weeks.
干预措施: Tailored Lighting Intervention (Device)
结局指标
主要结局
Metabolic control
时间窗: Done at Baseline, week 13 and 25
Changes in glucose homeostasis and insulin sensitivity will be measured using the Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT).
Metabolic control
时间窗: Done at Baseline, week 13 and 25
Changes in glucose homeostasis and insulin sensitivity will be measured using the Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT).
次要结局
- Melatonin Levels(One morning during Baseline, week 13, 25 and 48)
- Sleep disturbance(Done at Baseline, week 13, 25 and 48)
- Cognition(Done at Baseline, week 13, 25 and 48)
- Sleep disturbance using actigraphy(Done at Baseline, week 13, 25 and 48)
- Light measurements(Done at Baseline, week 13, 25 and 48)
- Depression(Done at Baseline, week 13, 25 and 48)
- Sleep disturbance using actigraphy(Done at Baseline, week 13, 25 and 48)
- Light measurements(Done at Baseline, week 13, 25 and 48)
- Melatonin Levels(One morning during Baseline, week 13, 25 and 48)
- Sleep disturbance(Done at Baseline, week 13, 25 and 48)
- Depression(Done at Baseline, week 13, 25 and 48)
- Cognition(Done at Baseline, week 13, 25 and 48)
研究者
Mariana Figueiro
Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai