Clinical trial NCT01082016: Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Deprivation
Keywords: Sleep
Critical Illness
Sleep promotion during recovery form illness
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Arizona Biomedical Research Commission (ABRC)
First posted: 2010-03-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Time in Rapid Eye Movement (REM) Sleep
timeFrame: Within 24 hours of enrollment
measure: Time in slow wave sleep
timeFrame: Within 24 hours of enrollment
Secondary outcomes:
measure: Systemic inflammatory mediators (cytokines)
timeFrame: Baseline and 12, 24, and 48 hours
measure: Safety profile
timeFrame: With 24 hours of enrollment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona College of Medicine
name: Randall S Friese, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.