NCT03568045已完成不适用
Feasibility Pilot of Bright Light in the Intensive Care Unit
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light
研究概览
简要总结
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.
详细描述
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial. Feasibility will be assessed via the following metrics: daytime bright light is acceptable and tolerable to patients and has high fidelity and sustainability as an intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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 ≥24 hours after enrollment
- •Age ≥50 years
- •History of hypertension based on chart review and presence of 1 or more home blood pressure medications
- •Able to understand English
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) OR 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 (<1% population) or blind/disease of the optic nerve
- •Current history of substance abuse including alcohol (use in last 30 days)
- •Current or recent (last 1 year) shiftwork
- •Home medications include: melatonin, melatonin agonist
- •Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility
- •History of bipolar disease (Bright light therapy possibly unsafe in this population).
- •Paralyzed (due to injury, disease or medications)
- •Diagnosed with hepatic encephalopathy in the setting of end-stage liver disease
结局指标
主要结局
Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light
时间窗: Study Day 2-5
Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.
次要结局
- Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light(Study Day 2-5)
- Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance.(Study Day 2-5)
- Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described(Study Day 1 (enrollment))
- Sustainability: Percent of Intended Intervention Days That the Device is Used.(Study Day 2-5)
研究者
研究点 (2)
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