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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280097
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : July 15, 2015
Masimo Labs
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Disruption and ICU Delirium: Delirium Assessment and Monitoring Combined With the Evaluation of Sleep Using the Sedline Brain Function Monitor.
Study Start Date : December 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Prospective cohort study
Observational only

Primary Outcome Measures :
  1. ICU delirium [ Time Frame: Daily measurement during study ]
    ICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.

Secondary Outcome Measures :
  1. Intensive Care Unit (ICU) length of stay [ Time Frame: Assessed at discharge from ICU ]
    The day of admission to the ICU until the day of discharge from the ICU.

  2. Hospital Length of Stay [ Time Frame: Assesses at discharge from hospital ]
    This is the persons length of stay in the hospital, from admission date until discharge date.

  3. ICU mortality [ Time Frame: Assessed at discharge from ICU ]
    We will collect data on mortality during the stay in the Intensive Care Unit

  4. Hospital mortality [ Time Frame: Assessed at discharge from hospital ]
    We will assess the mortality during the hospital stay.

  5. One year mortality [ Time Frame: Assessed at 1 year from admission to hospital ]
    We will assess mortality at one year from hospital admission.

Biospecimen Retention:   Samples With DNA
Blood will be collected as part of the study. It will be used to measure circadian markers that will include core body temperature, cortisol and melatonin rhythms. If subjects agree, some will be stored in a bank for future research.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include elderly patients admitted to the intensive care unit at UCSF.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280097

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0648
Sponsors and Collaborators
University of California, San Francisco
Masimo Labs
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Principal Investigator: Jacqueline M Leung, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT01280097    
Other Study ID Numbers: 10-02079
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015
Keywords provided by University of California, San Francisco:
Intensive care unit delirium
Sleep disruption
Sleep hygiene
Early mobilization in the Intensive care unit
Sedative agents and sleep
Circadian rhythm
Cognitive disorder
Electroencephalography (EEG) to measure sleep
Confusion Assessment Method in the Intensive Care Unit
Immune function
REM sleep
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Chronobiology Disorders
Occupational Diseases