Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
75 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal