Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Days of Delirium
研究概览
简要总结
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.
详细描述
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium. The objective is to conduct a randomized controlled trial to determine if a circadian entrainment intervention, daytime bright light, will promote circadian alignment and reduce days of delirium
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
- Single (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
- •Hospital admission ≤30 hours at noon on enrollment day
- •Expected to say in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment
- •Age ≥50 years
排除标准
- •At significant risk for pre-existing circadian abnormalities:
- •Severe chronic brain injury (Injury greater than 30 days ago resulting in the inability to live independently)
- •Acute brain injury of any severity (Injury less than 30 days ago including acute intracranial bleed, traumatic brain injury, central nervous system infection, tumor)
- •Documented circadian disorder or blind/disease of the optic nerve
- •Current history of substance abuse including alcohol (use in last 30 days)
- •Transferred from an outside hospital.
- •History of bipolar disease
- •Paralyzed (due to injury, disease or medications)
- •Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded; patients transferred from the MICU to the floor between 22:00 and 05:00 on subsequent study nights will continue in the study but be excluded from the primary analysis (estimated 10% of patients).
结局指标
主要结局
Days of Delirium
时间窗: Study Day 1-30 (patients will be censored at hospital discharge)
The approach is to measure days of delirium in our patient cohort. After enrollment, the investigators will check patients daily for delirium until hospital discharge or day 30.
Circadian Alignment
时间窗: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
The primary circadian outcome will be the proportion of daytime activity out of total activity (daytime proportion). Rest-activity patterns will be measured with the Actiwatch Spectrum (Philips Healthcare, Netherlands) set at 30-second epochs and placed on the patient's wrist. Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded from all analysis.
次要结局
- Circadian Alignment, Secondary Measures, Continous Heart Rate(Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Feasibility, Patient Tolerance Time(Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Feasibility, Patient Tolerance Symptoms(Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Sleep Efficiency(Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Circadian Alignment, Secondary Measures, Body surface temperature gradient(Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.(Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Feasibility, Intervention Fidelity(Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Feasibility, Intervention Sustainability(Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Total Sleep(Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).)
- Feasibility, Patient Acceptance(Study Day 1)