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

Delirium Clinical Trial

— SID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280097
• Other study ID #: 10-02079
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: July 13, 2015
• Start date: December 2010
• Est. completion date: November 2012

Study information

• Verified date: July 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium
• Parasomnias
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Masimo Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU delirium	ICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.	Daily measurement during study	No
Secondary	Intensive Care Unit (ICU) length of stay	The day of admission to the ICU until the day of discharge from the ICU.	Assessed at discharge from ICU	No
Secondary	Hospital Length of Stay	This is the persons length of stay in the hospital, from admission date until discharge date.	Assesses at discharge from hospital	No
Secondary	ICU mortality	We will collect data on mortality during the stay in the Intensive Care Unit	Assessed at discharge from ICU	No
Secondary	Hospital mortality	We will assess the mortality during the hospital stay.	Assessed at discharge from hospital	No
Secondary	One year mortality	We will assess mortality at one year from hospital admission.	Assessed at 1 year from admission to hospital	No