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

Study Overview
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Brief Summary
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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.

Conditions
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Sleep Deprivation

Intervention / Treatment
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* Other: Sleep Enhancement Program (SEP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Monitor sleep in ICU without attempts at promotion | |
| Experimental: Sleep promotion<br>Measure sleep in ICU with sleep promotion program in effect | Other: Sleep Enhancement Program (SEP)<br>* Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Critical Illness, Sleep promotion during recovery form illness