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

History of Changes

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

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:

Parthasarathy S, Friese RS, Ayas NT. Biological validity to sleep measurements during critical illness. Crit Care Med. 2010 Feb;38(2):705-6. No abstract available.

Friese RS. Good night, sleep tight: the time is ripe for critical care providers to wake up and focus on sleep. Crit Care. 2008;12(3):146. Epub 2008 May 12.

Friese RS, Diaz-Arrastia R, McBride D, Frankel H, Gentilello LM. Quantity and quality of sleep in the surgical intensive care unit: are our patients sleeping? J Trauma. 2007 Dec;63(6):1210-4.

Friese RS. Sleep and recovery from critical illness and injury: a review of theory, current practice, and future directions. Crit Care Med. 2008 Mar;36(3):697-705. Review.

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
Sleep Disorders
Nervous System Diseases

Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013

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