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Completed

NCT Number: NCT01280097

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Masimo Labs

Registry information

Official study title

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

Acronym: SID

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2011
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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