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

September 17, 2010 updated by: University of Arizona

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Rapid Eye Movement (REM) Sleep
Time Frame: Within 24 hours of enrollment
Polysomnography during sleep promotion protocol
Within 24 hours of enrollment
Time in slow wave sleep
Time Frame: Within 24 hours of enrollment
Polysomnography during sleep promotion protocol
Within 24 hours of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic inflammatory mediators (cytokines)
Time Frame: Baseline and 12, 24, and 48 hours
Blood draw for circulating mediaotors of inflammation
Baseline and 12, 24, and 48 hours
Safety profile
Time Frame: With 24 hours of enrollment
Monitor for adverse events during polysomnography
With 24 hours of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Arizona Biomedical Research Commission (ABRC)

Investigators

  • Principal Investigator: Randall S Friese, MD, University of Arizona College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Estimate)

September 20, 2010

Last Update Submitted That Met QC Criteria

September 17, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABRC 9-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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