Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
|ClinicalTrials.gov Identifier: NCT01082016|
Recruitment Status : Unknown
Verified March 2010 by University of Arizona.
Recruitment status was: Enrolling by invitation
First Posted : March 5, 2010
Last Update Posted : September 20, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Deprivation||Other: Sleep Enhancement Program (SEP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||June 2013|
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
- Time in Rapid Eye Movement (REM) Sleep [ Time Frame: Within 24 hours of enrollment ]Polysomnography during sleep promotion protocol
- Time in slow wave sleep [ Time Frame: Within 24 hours of enrollment ]Polysomnography during sleep promotion protocol
- Systemic inflammatory mediators (cytokines) [ Time Frame: Baseline and 12, 24, and 48 hours ]Blood draw for circulating mediaotors of inflammation
- Safety profile [ Time Frame: With 24 hours of enrollment ]Monitor for adverse events during polysomnography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082016
|United States, Arizona|
|University Medical Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Randall S Friese, MD||University of Arizona College of Medicine|