- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01061242
Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance
June 22, 2011 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
MICU staff will implement multi-faceted, staged sleep promoting interventions as part of a pre-existing sleep quality improvement project.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Digit span test score
Time Frame: within 96 hours of Intensive Care Unit (ICU) discharge
|
within 96 hours of Intensive Care Unit (ICU) discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sleep in the ICU Questionnaire
Time Frame: within 96 hours of ICU discharge
|
within 96 hours of ICU discharge
|
Trail Making Test (Part A + B) times
Time Frame: within 96 hours of ICU discharge
|
within 96 hours of ICU discharge
|
Delirium status
Time Frame: within 96 hours of ICU discharge
|
within 96 hours of ICU discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
February 2, 2010
First Submitted That Met QC Criteria
February 2, 2010
First Posted (Estimate)
February 3, 2010
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 22, 2011
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00033951
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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