Study of Sleep and Delirium in the Intensive Care Unit (ICU) (SID)

Sleep Disruption and ICU Delirium: Delirium Assessment and Monitoring Combined With the Evaluation of Sleep Using the Sedline Brain Function Monitor.

The investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium.

Study Overview

• Status: Completed
• Conditions: Delirium; Sleep Disorders, Circadian Rhythm

Detailed Description

Delirium and sleep disruption are both common in the intensive care unit (ICU). Delirium is a state of acute confusion, experienced especially by older adults admitted to the hospital, with the potential to adversely impact patients' outcome. Of hospitalized patients, the highest rate of delirium occurs in elderly patients in the ICU. Development of ICU delirium is associated with longer ICU and hospital length of stay, significantly higher risk of functional decline, loss of independent living, and increased mortality. Previous studies have focused on describing the clinical manifestations, risk factors and outcomes of ICU delirium; yet, the contribution of sleep timing, as well as its quality and quantity, to the development of delirium, has not previously been rigorously investigated. Sleep disturbance, including changes in sleep patterns and architecture, and decreased quality of sleep are commonly observed in older subjects. In the ICU, environmental factors (such as noise levels and continuous ambient light) and health care practices (such as frequent performance of medical procedures and tests) further contribute to sleep disruption in the critically ill older patients. Additionally, many sedative and analgesic agents potently suppress slow wave sleep. In preliminary data acquired from ICU patients, the investigators have observed that fragmented sleep is prevalent due to frequent arousals and awakenings, and that sleep architecture is altered with an increase in light sleep, and a decrease in restorative slow wave sleep. Despite the common occurrence of both ICU delirium and sleep disruption, it is not known whether sleep disruption increases the risk of developing delirium in the critically ill older patients. In this exploratory study, the investigators propose to test the hypothesis that the severity and duration of sleep disruption is an independent predictor of the onset and duration of ICU delirium in a cohort of older ICU patients. The investigators will measure sleep disruption using continuous processed electroencephalography and measure ICU delirium using a well-validated and reliable standardized instrument. Results from this study will inform the contribution of sleep disruption in the development of ICU delirium in the older critically ill patients.

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143-0648
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include elderly patients admitted to the intensive care unit at UCSF.

Description

Inclusion Criteria:

• patients ≥ 45 years of age admitted to the ICU, and remain for at least 24 hours.

Exclusion Criteria:

• status post craniotomy,
• moribund state with planned withdrawal of life support,
• severe dementia,
• substantial hearing impairment or inability to understand English.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Prospective cohort study; Observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU delirium	ICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.	Daily measurement during study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Unit (ICU) length of stay	The day of admission to the ICU until the day of discharge from the ICU.	Assessed at discharge from ICU
Hospital Length of Stay	This is the persons length of stay in the hospital, from admission date until discharge date.	Assesses at discharge from hospital
ICU mortality	We will collect data on mortality during the stay in the Intensive Care Unit	Assessed at discharge from ICU
Hospital mortality	We will assess the mortality during the hospital stay.	Assessed at discharge from hospital
One year mortality	We will assess mortality at one year from hospital admission.	Assessed at 1 year from admission to hospital

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Masimo Labs
• Investigators: Principal Investigator: Jacqueline M Leung, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 20, 2011

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Sleep hygiene; Circadian rhythm; Immune function; REM sleep; Sleep disruption; Cognitive disorder; Intensive care unit delirium; Early mobilization in the Intensive care unit; Sedative agents and sleep; Electroencephalography (EEG) to measure sleep; Confusion Assessment Method in the Intensive Care Unit
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Occupational Diseases; Chronobiology Disorders; Delirium; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 10-02079