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Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance

Primary Purpose

Neurobehavioral Manifestations, Sleep Deprivation, Dyssomnias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep promoting interventions
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurobehavioral Manifestations focused on measuring Neurocognitive function, Sleep quality, Critical care, Quality Assurance, health care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline

Sleep Promotion Group

Arm Description

Post-Intensive Care Unit (ICU) neurocognitive testing and sleep survey performed on patients exposed to ad-lib Medical ICU environment.

Post-ICU neurocognitive testing and sleep survey performed on patients exposed to interventions in the pre-existing MICU sleep quality improvement project.

Outcomes

Primary Outcome Measures

Digit span test score

Secondary Outcome Measures

Sleep in the ICU Questionnaire
Trail Making Test (Part A + B) times
Delirium status

Full Information

First Posted
February 2, 2010
Last Updated
June 22, 2011
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01061242
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurobehavioral Manifestations, Sleep Deprivation, Dyssomnias
Keywords
Neurocognitive function, Sleep quality, Critical care, Quality Assurance, health care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Post-Intensive Care Unit (ICU) neurocognitive testing and sleep survey performed on patients exposed to ad-lib Medical ICU environment.
Arm Title
Sleep Promotion Group
Arm Type
Experimental
Arm Description
Post-ICU neurocognitive testing and sleep survey performed on patients exposed to interventions in the pre-existing MICU sleep quality improvement project.
Intervention Type
Behavioral
Intervention Name(s)
Sleep promoting interventions
Intervention Description
MICU staff will implement multi-faceted, staged sleep promoting interventions as part of a pre-existing sleep quality improvement project.
Primary Outcome Measure Information:
Title
Digit span test score
Time Frame
within 96 hours of Intensive Care Unit (ICU) discharge
Secondary Outcome Measure Information:
Title
Sleep in the ICU Questionnaire
Time Frame
within 96 hours of ICU discharge
Title
Trail Making Test (Part A + B) times
Time Frame
within 96 hours of ICU discharge
Title
Delirium status
Time Frame
within 96 hours of ICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance

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