Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit

Status unconfirmed · Not applicable

Conditions studied: Sleep Deprivation

In brief

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.

Key facts

Study ID

NCT01082016

Run by

University of Arizona

People needed

75

Starts

2010-04-01

Expected to finish

2013-06-01

Last updated by the study team

2010-09-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Pregnancy
• Incarceration
• Admission diagnosis of Closed Head Injury or Traumatic Brain Injury
• Evidence of delirium on Confusion Assessment Method (CAM-ICU) Score
• Hemodynamic Instability
• Sepsis
• Multiple Organ Dysfunction
• Acute Renal Failure
• Known history of sleep disorder
• Known Psychiatric disorder

Where it is running

• University Medical Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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