Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
- Time in Rapid Eye Movement (REM) Sleep [ Time Frame: Within 24 hours of enrollment ] [ Designated as safety issue: No ]Polysomnography during sleep promotion protocol
- Time in slow wave sleep [ Time Frame: Within 24 hours of enrollment ] [ Designated as safety issue: No ]Polysomnography during sleep promotion protocol
- Systemic inflammatory mediators (cytokines) [ Time Frame: Baseline and 12, 24, and 48 hours ] [ Designated as safety issue: No ]Blood draw for circulating mediaotors of inflammation
- Safety profile [ Time Frame: With 24 hours of enrollment ] [ Designated as safety issue: Yes ]Monitor for adverse events during polysomnography
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
No Intervention: Control
Monitor sleep in ICU without attempts at promotion
Experimental: Sleep promotion
Measure sleep in ICU with sleep promotion program in effect
Other: Sleep Enhancement Program (SEP)
Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082016
|United States, Arizona|
|University Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Randall S Friese, MD||University of Arizona College of Medicine|