Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance

NCT01061242 | Completed

• 1 other identifier: NA_00033951
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurobehavioral Manifestations; Sleep Deprivation; Dyssomnias

Keywords

Neurocognitive function; Sleep quality; Critical care; Quality Assurance, health care

Outcome Measures

Primary Outcomes (1)

• Digit span test score

  within 96 hours of Intensive Care Unit (ICU) discharge

Secondary Outcomes (3)

• 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

Study Arms (2)

Baseline

NO INTERVENTION

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

Sleep Promotion Group

EXPERIMENTAL

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

Behavioral: Sleep promoting interventions

Interventions

Sleep promoting interventions BEHAVIORAL

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

Sleep Promotion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Neurobehavioral Manifestations; Sleep Deprivation; Dyssomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders; Sleep Disorders, Intrinsic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 23, 2011

Record last verified: 2009-12

Locations

US (1)