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

Sleep Deprivation Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01082016
• Other study ID #: ABRC 9-022
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 4, 2010
• Last updated: September 17, 2010
• Start date: April 2010
• Est. completion date: June 2013

Study information

• Verified date: March 2010
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• Sleep Enhancement Program (SEP)
Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients

Locations

Country	Name	City	State
United States	University Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Arizona Biomedical Research Commission (ABRC)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in Rapid Eye Movement (REM) Sleep	Polysomnography during sleep promotion protocol	Within 24 hours of enrollment	No
Primary	Time in slow wave sleep	Polysomnography during sleep promotion protocol	Within 24 hours of enrollment	No
Secondary	Systemic inflammatory mediators (cytokines)	Blood draw for circulating mediaotors of inflammation	Baseline and 12, 24, and 48 hours	No
Secondary	Safety profile	Monitor for adverse events during polysomnography	With 24 hours of enrollment	Yes