The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Dynamic Light Therapy : A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes of the circadian rhythm during admission by heart-rate-variation-analysis
研究概览
简要总结
By using subjective and objective measurements, the investigators monitor the change of circadian rhythm in Intensive Care Unit (ICU) patients with acute myocardial infarction and the effect of light therapy.
详细描述
The investigators include 70 patients who are admitted to coronary care unit due to coronary artery disease, with severity between Killip I-III and age between 35-85. Participants are randomly assigned to 2 groups, the experimental group (blue light) and the placebo group (white light). Both groups receive light therapy or white light daily between 8am to 12pm. The investigators use actigraphy and heart rate variation analysis, and check melatonin level as objective measurements. The investigators use delirium scales to evaluate delirium and its severity. The light therapy is stopped once a participant is diagnosed of delirium or transferred, and the investigators keep following participants until discharge to evaluate the prognosis.
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 (Participant)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis for admission is acute myocardial infarction with severity between Killip I-III.
- •Age is between 35-
- •Participants who are willing to participate in the study and sign the informed consent.
排除标准
- •Using sedative hypnotic drugs.
- •Blindness or severe cataract.
- •Neurological diseases such as epilepsy, brain injury, or stroke.
- •Severe mental disorder such as major depressive disorder, bipolar disorder, schizophrenia, intellectual disability or substance use disorders.
- •Unable to communicate.
- •Participants who are unwilling to participate in the study or refuse to sign the informed consent.
- •Participants who are not suitable to include in this study, evaluate by PI or Co-PI.
结局指标
主要结局
Changes of the circadian rhythm during admission by heart-rate-variation-analysis
时间窗: baseline for 48hours, and 24hours before discharge
heart-rate-variation-analysis data
Changes of Melatonin level
时间窗: collect saliva in the morning and at the night of Day 1 and the day of discharge
Melatonin level
Changes of the circadian rhythm during admission by actigraphy
时间窗: an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks
Actigraphy data
Changes of Vitamin D level
时间窗: blood sampling at Day 1 and the day of discharge
Vitamin D level
次要结局
- Confusion Assessment Method for the Intensive Care Unit(evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks)
- Intensive Care Delirium Screen Checklist(evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks)