University of California, San Francisco
San Francisco, California, 94143-0648, United States
NCT Number: NCT01280097
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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Notify Me45 year and older
All sexes
Observational
San Francisco, California, 94143-0648, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Daily measurement during study
ICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.
Time frame: Assessed at discharge from ICU
The day of admission to the ICU until the day of discharge from the ICU.
Time frame: Assesses at discharge from hospital
This is the persons length of stay in the hospital, from admission date until discharge date.
Time frame: Assessed at discharge from ICU
We will collect data on mortality during the stay in the Intensive Care Unit
Time frame: Assessed at discharge from hospital
We will assess the mortality during the hospital stay.
Time frame: Assessed at 1 year from admission to hospital
We will assess mortality at one year from hospital admission.
University of California, San Francisco
Other
Sleep Disruption and ICU Delirium: Delirium Assessment and Monitoring Combined With the Evaluation of Sleep Using the Sedline Brain Function Monitor.
Acronym: SID
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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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