跳至主要内容
临床试验/NCT04953767
NCT04953767招募中不适用

The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Dynamic Light Therapy : A Preliminary Study

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年5月12日最近更新:
适应症

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

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)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验