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| Name | Class |
|---|---|
| Arizona Biomedical Research Commission (ABRC) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Monitor sleep in ICU without attempts at promotion | |
| Sleep promotion | Experimental | Measure sleep in ICU with sleep promotion program in effect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Enhancement Program (SEP) | Other | Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall S Friese, MD | University of Arizona College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20083935 | Background | Parthasarathy S, Friese RS, Ayas NT. Biological validity to sleep measurements during critical illness. Crit Care Med. 2010 Feb;38(2):705-6. doi: 10.1097/CCM.0b013e3181cbb05f. No abstract available. | |
| 18492219 | Background | 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. doi: 10.1186/cc6884. Epub 2008 May 12. |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| With 24 hours of enrollment |
| 18212640 | Background | 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. doi: 10.1097/TA.0b013e31815b83d7. |
| 18176314 | Background | 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. doi: 10.1097/CCM.0B013E3181643F29. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |