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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Arizona Biomedical Research Commission (ABRC)
Information provided by:
University of Arizona

Brief Summary:

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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time in Rapid Eye Movement (REM) Sleep [ Time Frame: Within 24 hours of enrollment ]
    Polysomnography during sleep promotion protocol

  2. Time in slow wave sleep [ Time Frame: Within 24 hours of enrollment ]
    Polysomnography during sleep promotion protocol

Secondary Outcome Measures :
  1. Systemic inflammatory mediators (cytokines) [ Time Frame: Baseline and 12, 24, and 48 hours ]
    Blood draw for circulating mediaotors of inflammation

  2. Safety profile [ Time Frame: With 24 hours of enrollment ]
    Monitor for adverse events during polysomnography

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01082016

United States, Arizona
University Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Arizona Biomedical Research Commission (ABRC)
Principal Investigator: Randall S Friese, MD University of Arizona College of Medicine

Responsible Party: Randall Friese, MD Associate Professor of Surgery, University of Arizona College of Medicine Identifier: NCT01082016     History of Changes
Other Study ID Numbers: ABRC 9-022
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: September 20, 2010
Last Verified: March 2010

Keywords provided by University of Arizona:
Critical Illness
Sleep promotion during recovery form illness

Additional relevant MeSH terms:
Sleep Deprivation
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders