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Status unknownNCT01082016Updated Sep 20, 2010

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

An interventional study of Sleep Enhancement Program (SEP) in Sleep Deprivation, sponsored by University of Arizona. Status unknown at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2010-09-20.

Sponsored by University of Arizona · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Mar 2010), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Deprivation

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Keywords

  • Sleep
  • Critical Illness
  • Sleep promotion during recovery form illness
03

In context

Sleep Deprivation

300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.

This study's planned enrollment of 75 is above the median of 45 across 248 interventional studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

University of Arizona is the lead sponsor of 465 studies on the registry; 86 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • No intervention
    Control

    Monitor sleep in ICU without attempts at promotion

  • Experimental
    Sleep promotion

    Measure sleep in ICU with sleep promotion program in effect

    Other: Sleep Enhancement Program (SEP)

Interventions

  • OtherSleep Enhancement Program (SEP)

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

06

What researchers measure

Primary outcomes

  1. Time in Rapid Eye Movement (REM) Sleep

    Polysomnography during sleep promotion protocol

    Time frame: Within 24 hours of enrollment

  2. Time in slow wave sleep

    Polysomnography during sleep promotion protocol

    Time frame: Within 24 hours of enrollment

Secondary outcomes

  1. Systemic inflammatory mediators (cytokines)

    Blood draw for circulating mediaotors of inflammation

    Time frame: Baseline and 12, 24, and 48 hours

  2. Safety profile

    Monitor for adverse events during polysomnography

    Time frame: With 24 hours of enrollment

07

Study locations

1 site
  • University Medical Center
    Tucson, Arizona 85724, United States
08

References and documents

Publications

  • 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. PubMed 20083935 ↗
  • 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. PubMed 18492219 ↗
  • 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. PubMed 18212640 ↗
  • 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. PubMed 18176314 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01082016
Lead sponsor
University of Arizona
Collaborators
Arizona Biomedical Research Commission (ABRC)
First posted
Mar 5, 2010
Start date
Apr 2010
Primary completion
Jan 2013 (estimated)
Completion
Jun 2013 (estimated)
Last update
Sep 20, 2010

Study contacts

Randall S Friese, MD
principal investigator · University of Arizona College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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