Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance

Sleep Deprivation Clinical Trial

Official title:

Post-ICU Neurocognitive Performance and Sleep Quality Ratings Following Exposure to a Medical ICU Sleep Quality Improvement Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061242
• Other study ID #: NA_00033951
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: June 22, 2011
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: December 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dyssomnias
• Neurobehavioral Manifestations
• Sleep Deprivation

Intervention

Behavioral:
• Sleep promoting interventions
MICU staff will implement multi-faceted, staged sleep promoting interventions as part of a pre-existing sleep quality improvement project.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digit span test score		within 96 hours of Intensive Care Unit (ICU) discharge	No
Secondary	Sleep in the ICU Questionnaire		within 96 hours of ICU discharge	No
Secondary	Trail Making Test (Part A + B) times		within 96 hours of ICU discharge	No
Secondary	Delirium status		within 96 hours of ICU discharge	No