Clinical trial NCT01280097: Study of Sleep and Delirium in the Intensive Care Unit (ICU)
Official title: Sleep Disruption and ICU Delirium: Delirium Assessment and Monitoring Combined With the Evaluation of Sleep Using the Sedline Brain Function Monitor.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Sleep Disorders, Circadian Rhythm
Keywords: 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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Masimo Labs
First posted: 2011-01-20
Enrollment: 57
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include elderly patients admitted to the intensive care unit at UCSF.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ICU delirium
timeFrame: Daily measurement during study
Secondary outcomes:
measure: Intensive Care Unit (ICU) length of stay
timeFrame: Assessed at discharge from ICU
measure: Hospital Length of Stay
timeFrame: Assesses at discharge from hospital
measure: ICU mortality
timeFrame: Assessed at discharge from ICU
measure: Hospital mortality
timeFrame: Assessed at discharge from hospital
measure: One year mortality
timeFrame: Assessed at 1 year from admission to hospital
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jacqueline M Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: