Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01082016
Enrollment
75
Registered
2010-03-05
Start date
2010-04-30
Completion date
2013-06-30
Last updated
2010-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Deprivation

Keywords

Sleep, Critical Illness, Sleep promotion during recovery form illness

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.

Interventions

OTHERSleep Enhancement Program (SEP)

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

Sponsors

Arizona Biomedical Research Commission (ABRC)
CollaboratorOTHER
University of Arizona
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Time in Rapid Eye Movement (REM) SleepWithin 24 hours of enrollmentPolysomnography during sleep promotion protocol
Time in slow wave sleepWithin 24 hours of enrollmentPolysomnography during sleep promotion protocol

Secondary

MeasureTime frameDescription
Systemic inflammatory mediators (cytokines)Baseline and 12, 24, and 48 hoursBlood draw for circulating mediaotors of inflammation
Safety profileWith 24 hours of enrollmentMonitor for adverse events during polysomnography

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026