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
- 1
- 主要终点
- Circadian Alignment
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)
- •3. 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).
研究组 & 干预措施
Bright Light
Intervention: Daytime Bright Light
Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1.
Patients will undergo monitoring (light levels, circadian alignment), starting on study day 1. Patients will be exposed to bright light from 09:00 to 13:00 starting on study day 2 and continuing through study day 5 or MICU discharge whichever is longer up to 30 days. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor, if the patient is transferred (prior to study day 5). Feasibility metrics will also be collected.
干预措施: Daytime Bright Light (Device)
Usual Light
Intervention: Usual Care
Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1.
Patients will undergo monitoring (light levels, circadian alignment), but otherwise, have usual care.
干预措施: Usual Light (Device)
结局指标
主要结局
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.
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.
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)