Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance

Not Applicable

Completed

• Conditions: Neurobehavioral Manifestations; Sleep Deprivation; Dyssomnias
• Interventions: Behavioral: Sleep promoting interventions

• Registration Number: NCT01061242
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

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 Timeline

• Status Verified: 2009-12
• Study Start: 2010-01
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Promotion Group	Sleep promoting interventions	Post-ICU neurocognitive testing and sleep survey performed on patients exposed to interventions in the pre-existing MICU sleep quality improvement project.

Primary Outcome Measures

Name	Time	Method
Digit span test score	within 96 hours of Intensive Care Unit (ICU) discharge

Secondary Outcome Measures

Name	Time	Method
Sleep in the ICU Questionnaire	within 96 hours of ICU discharge
Trail Making Test (Part A + B) times	within 96 hours of ICU discharge
Delirium status	within 96 hours of ICU discharge

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States