Trials / Unknown
UnknownNCT01082016
Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Sleep Enhancement Program (SEP) | Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2013-01-01
- Completion
- 2013-06-01
- First posted
- 2010-03-05
- Last updated
- 2010-09-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01082016. Inclusion in this directory is not an endorsement.