Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01061242
First received: February 2, 2010
Last updated: June 22, 2011
Last verified: December 2009

February 2, 2010
June 22, 2011
January 2010
July 2010   (final data collection date for primary outcome measure)
Digit span test score [ Time Frame: within 96 hours of Intensive Care Unit (ICU) discharge ] [ Designated as safety issue: No ]
Digit span test score [ Time Frame: within 96 hours of ICU discharge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01061242 on ClinicalTrials.gov Archive Site
  • Sleep in the ICU Questionnaire [ Time Frame: within 96 hours of ICU discharge ] [ Designated as safety issue: No ]
  • Trail Making Test (Part A + B) times [ Time Frame: within 96 hours of ICU discharge ] [ Designated as safety issue: No ]
  • Delirium status [ Time Frame: within 96 hours of ICU discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance
Post-ICU Neurocognitive Performance and Sleep Quality Ratings Following Exposure to a Medical ICU Sleep Quality Improvement Project

The purpose of this study is to understand patients' neurocognitive performance shortly after discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that post-ICU neurocognitive function and patient overall ICU sleep experience will improve through a pre-existing MICU sleep improvement initiative.

Despite decades of scientific interest in evaluating sleep among critically ill patients, little is known about the effects of intensive care unit (ICU)-associated sleep disturbances on patient outcomes. Furthermore, few interventions have been rigorously evaluated to demonstrate efficacy in improving sleep in the ICU and associated patient outcomes. Post-ICU neurocognitive test performance data from this study will be linked to a pre-existing Quality Improvement (QI) project for patient sleep in the MICU. We hypothesize that patients' post-ICU neurocognitive performance (delirium status, attention, short-term memory, processing speed, and executive function) will positively correlate with scores from a previously-published Sleep in the Intensive Care Unit Questionnaire. In addition, we hypothesize that both neurocognitive performance and the Sleep in the Intensive Care Unit Questionnaire will improve during the multi-stage MICU-wide sleep QI project. Our project will provide valuable empirical evidence to help support guidelines for promoting sleep in the ICU setting.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Neurobehavioral Manifestations
  • Sleep Deprivation
  • Dyssomnias
Behavioral: Sleep promoting interventions
MICU staff will implement multi-faceted, staged sleep promoting interventions as part of a pre-existing sleep quality improvement project.
  • No Intervention: Baseline
    Post-Intensive Care Unit (ICU) neurocognitive testing and sleep survey performed on patients exposed to ad-lib Medical ICU environment.
  • Experimental: Sleep Promotion Group
    Post-ICU neurocognitive testing and sleep survey performed on patients exposed to interventions in the pre-existing MICU sleep quality improvement project.
    Intervention: Behavioral: Sleep promoting interventions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • >=18 years old
  • Spent at least one full night (i.e. 7pm to 7am) in the Johns Hopkins Hospital (JHH) Medical Intensive Care Unit (MICU).
  • Discharged directly from MICU to an in-patient medical step-down or ward bed at JHH.

Exclusion Criteria:

  • Previously enrolled in the study (i.e. repeat discharge from MICU)
  • Pre-existing cognitive impairment, including hepatic encephalopathy, long-term alcohol abuse, and neurological disease (e.g., dementia, prior stroke, cerebral palsy, traumatic brain injury, active seizures)
  • Unable to speak and/or understand English
  • > 96 hours between MICU discharge and testing
  • Visual or hearing impairment, inability to read, or inability to use a writing instrument preventing administration of the neurocognitive tests
  • Spent at least one night in an ICU other than JHH MICU during current hospitalization
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01061242
NA_00033951
No
Dale M. Needham, MD, PhD, Johns Hopkins University
Johns Hopkins University
Not Provided
Not Provided
Johns Hopkins University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP