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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Arizona Biomedical Research Commission (ABRC)
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT01082016
First received: March 4, 2010
Last updated: September 17, 2010
Last verified: March 2010

March 4, 2010
September 17, 2010
April 2010
January 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01082016 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
Not Provided

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Sleep Deprivation
Other: Sleep Enhancement Program (SEP)
Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients
  • No Intervention: Control
    Monitor sleep in ICU without attempts at promotion
  • Experimental: Sleep promotion
    Measure sleep in ICU with sleep promotion program in effect
    Intervention: Other: Sleep Enhancement Program (SEP)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
75
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01082016
ABRC 9-022
Yes
Randall Friese, MD Associate Professor of Surgery, University of Arizona College of Medicine
University of Arizona
Arizona Biomedical Research Commission (ABRC)
Principal Investigator: Randall S Friese, MD University of Arizona College of Medicine
University of Arizona
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP