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Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061242
First Posted: February 3, 2010
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johns Hopkins University
  Purpose
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.

Condition Intervention
Neurobehavioral Manifestations Sleep Deprivation Dyssomnias Behavioral: Sleep promoting interventions

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Post-ICU Neurocognitive Performance and Sleep Quality Ratings Following Exposure to a Medical ICU Sleep Quality Improvement Project

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Digit span test score [ Time Frame: within 96 hours of Intensive Care Unit (ICU) discharge ]

Secondary Outcome Measures:
  • Sleep in the ICU Questionnaire [ Time Frame: within 96 hours of ICU discharge ]
  • Trail Making Test (Part A + B) times [ Time Frame: within 96 hours of ICU discharge ]
  • Delirium status [ Time Frame: within 96 hours of ICU discharge ]

Enrollment: 88
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Sleep promoting interventions
MICU staff will implement multi-faceted, staged sleep promoting interventions as part of a pre-existing sleep quality improvement project.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061242


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
  More Information

Responsible Party: Dale M. Needham, MD, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01061242     History of Changes
Other Study ID Numbers: NA_00033951
First Submitted: February 2, 2010
First Posted: February 3, 2010
Last Update Posted: June 23, 2011
Last Verified: December 2009

Keywords provided by Johns Hopkins University:
Neurocognitive function
Sleep quality
Critical care
Quality Assurance, health care

Additional relevant MeSH terms:
Sleep Deprivation
Neurobehavioral Manifestations
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders


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