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

Not Applicable

• Conditions: Sleep Deprivation
• Interventions: Other: Sleep Enhancement Program (SEP)

• Registration Number: NCT01082016
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Study Start: 2010-04
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-20
• Primary Completion: 2013-01
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep promotion	Sleep Enhancement Program (SEP)	Measure sleep in ICU with sleep promotion program in effect

Primary Outcome Measures

Name	Time	Method
Time in Rapid Eye Movement (REM) Sleep	Within 24 hours of enrollment	Polysomnography during sleep promotion protocol
Time in slow wave sleep	Within 24 hours of enrollment	Polysomnography during sleep promotion protocol

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center; 🇺🇸 Tucson, Arizona, United States