Study of Sleep and Delirium in the Intensive Care Unit (ICU) (SID)
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.
Sleep Disorders, Circadian Rhythm
|Study Design:||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.|
- ICU delirium [ Time Frame: Daily measurement during study ] [ Designated as safety issue: No ]ICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.
- Intensive Care Unit (ICU) length of stay [ Time Frame: Assessed at discharge from ICU ] [ Designated as safety issue: No ]The day of admission to the ICU until the day of discharge from the ICU.
- Hospital Length of Stay [ Time Frame: Assesses at discharge from hospital ] [ Designated as safety issue: No ]This is the persons length of stay in the hospital, from admission date until discharge date.
- ICU mortality [ Time Frame: Assessed at discharge from ICU ] [ Designated as safety issue: No ]We will collect data on mortality during the stay in the Intensive Care Unit
- Hospital mortality [ Time Frame: Assessed at discharge from hospital ] [ Designated as safety issue: No ]We will assess the mortality during the hospital stay.
- One year mortality [ Time Frame: Assessed at 1 year from admission to hospital ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Prospective cohort 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280097
|Contact: Gabriela Meckler, BSemail@example.com|
|Contact: Stacey Newman, BAfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143-0648|
|Contact: Gabriela Meckler 415-476-9489 email@example.com|
|Contact: Stacey Newman 415-476-8612 firstname.lastname@example.org|
|Principal Investigator: Jacqueline M Leung, MD, MPH|
|Sub-Investigator: Michael Gropper, PhD, MD|
|Sub-Investigator: Mervyn Maze, MB ChB|
|Sub-Investigator: Susana Vacas, MD|
|Principal Investigator:||Jacqueline M Leung, MD||University of California, San Francisco|