Clinical trial NCT01061242: Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance
Official title: Post-ICU Neurocognitive Performance and Sleep Quality Ratings Following Exposure to a Medical ICU Sleep Quality Improvement Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurobehavioral Manifestations
Sleep Deprivation
Dyssomnias
Keywords: Neurocognitive function
Sleep quality
Critical care
Quality Assurance, health care
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2010-02-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Digit span test score
timeFrame: within 96 hours of Intensive Care Unit (ICU) discharge
Secondary outcomes:
measure: Sleep in the ICU Questionnaire
timeFrame: within 96 hours of ICU discharge
measure: Trail Making Test (Part A + B) times
timeFrame: within 96 hours of ICU discharge
measure: Delirium status
timeFrame: within 96 hours of ICU discharge
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References: