Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Time in Rapid Eye Movement (REM) Sleep
研究概览
简要总结
Sleep deprivation in healthy volunteers is associated with immune dysfunction. This adverse effect of sleep deprivation likely occurs in patients suffering from acute injury and critical illness requiring intensive care unit (ICU) admission. Studies have demonstrated that sleep in ICU patients is highly abnormal. The global hypothesis for this proposal is that a strategy to promote sleep in ICU patients will increase time in rapid eye movement (REM) and slow wave sleep (SWS). This three phase proposal examines the feasibility of a sleep promotion strategy for injured and critically ill patients in the ICU.
Phase I (Development and Training): Develop an intervention manual for sleep promotion, Sleep Enhancement Program (SEP), and train ICU staff.
Phase II (Validation and Safety): Implement SEP and test for protocol fidelity and safety.
Phase III (Efficacy): Conduct a pilot trail to determine efficacy of SEP to improve SWS in ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received care in ICU for at least 3 days
- •Received care in ICU no longer than 14 days
- •Score of 3 to 5 on the Riker Sedation-Agitation Scale (SAS)
- •Age < 55 years
- •Able to tolerate PO or have gastric access present (Nasogastric/Orogastric/PEG)
排除标准
- •Pregnancy
- •Incarceration
- •Admission diagnosis of Closed Head Injury or Traumatic Brain Injury
- •Evidence of delirium on Confusion Assessment Method (CAM-ICU) Score
- •Hemodynamic Instability
- •Multiple Organ Dysfunction
- •Acute Renal Failure
- •Known history of sleep disorder
- •Known Psychiatric disorder
结局指标
主要结局
Time in Rapid Eye Movement (REM) Sleep
时间窗: Within 24 hours of enrollment
Polysomnography during sleep promotion protocol
Time in slow wave sleep
时间窗: Within 24 hours of enrollment
Polysomnography during sleep promotion protocol
次要结局
- Systemic inflammatory mediators (cytokines)(Baseline and 12, 24, and 48 hours)
- Safety profile(With 24 hours of enrollment)