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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
  Purpose

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 Intervention
Sleep Deprivation
Other: Sleep Enhancement Program (SEP)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 75
Study Start Date: April 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082016

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

Publications:
Responsible Party: Randall Friese, MD Associate Professor of Surgery, University of Arizona College of Medicine
ClinicalTrials.gov Identifier: NCT01082016     History of Changes
Other Study ID Numbers: ABRC 9-022
Study First Received: March 4, 2010
Last Updated: September 17, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014