NCT01082016.

Trial name or title	Sleep promotion in critically ill and injured patients cared for in the intensive care unit
Methods	Interventional study
Participants	Inclusion criteria Received care in ICU for at least 3 days Received care in ICU for no longer than 14 days Score of 3 to 5 on the Riker Sedation‐Agitation Scale (SAS) Aged 18 years to 55 years Able to tolerate PO or have gastric access present (nasogastric/orogastric/PEG) Exclusion criteria Pregnancy Incarceration Admission diagnosis of closed head injury or traumatic brain injury Evidence of delirium on Confusion Assessment Method (CAM‐ICU) Score Haemodynamic instability Sepsis Multiple organ dysfunction Acute renal failure Known history of sleep disorder Known psychiatric disorder
Interventions	Experimental: sleep promotion No intervention: control
Outcomes	Primary outcomes Polysomnography during sleep promotion protocol. Time in rapid eye movement (REM) Sleep Time in slow‐wave sleep Secondary outcomes Systemic inflammatory mediators (cytokines) Safety profile
Starting date	April 2010
Contact information	Randall S Friese, MD University of Arizona College of Medicine
Notes	"Status unknown" (last update 2010)