NCT01082016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 20, 2010

Status Verified

March 1, 2010

Enrollment Period

2.8 years

First QC Date

March 4, 2010

Last Update Submit

September 17, 2010

Conditions

Sleep Deprivation

Keywords

SleepCritical IllnessSleep promotion during recovery form illness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Systemic inflammatory mediators (cytokines)

    Baseline and 12, 24, and 48 hours

  • Safety profile

    With 24 hours of enrollment

Study Arms (2)

Control

NO INTERVENTION

Monitor sleep in ICU without attempts at promotion

Sleep promotion

EXPERIMENTAL

Measure sleep in ICU with sleep promotion program in effect

Other: Sleep Enhancement Program (SEP)

Interventions

Sleep Enhancement Program (SEP)OTHER

Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients

Sleep promotion

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Tucson, Arizona, 85724, United States

Location

Related Publications (4)

  • 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.

    PMID: 20083935BACKGROUND

  • 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.

    PMID: 18492219BACKGROUND

  • 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.

    PMID: 18212640BACKGROUND

  • 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.

    PMID: 18176314BACKGROUND

MeSH Terms

Conditions

Sleep DeprivationCritical Illness

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDisease AttributesPathologic Processes

Study Officials

  • Randall S Friese, MD

    University of Arizona College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

September 20, 2010

Record last verified: 2010-03

Locations

US(1)