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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01280097
Acronym
SID
Enrollment
57
Registered
2011-01-20
Start date
2010-12-31
Completion date
2012-11-30
Last updated
2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

Masimo Labs
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ICU deliriumDaily measurement during studyICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.

Secondary

MeasureTime frameDescription
Intensive Care Unit (ICU) length of stayAssessed at discharge from ICUThe day of admission to the ICU until the day of discharge from the ICU.
Hospital Length of StayAssesses at discharge from hospitalThis is the persons length of stay in the hospital, from admission date until discharge date.
ICU mortalityAssessed at discharge from ICUWe will collect data on mortality during the stay in the Intensive Care Unit
Hospital mortalityAssessed at discharge from hospitalWe will assess the mortality during the hospital stay.
One year mortalityAssessed at 1 year from admission to hospitalWe will assess mortality at one year from hospital admission.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026