Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Masimo Labs
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01280097
First received: January 18, 2011
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition
Delirium
Sleep Disorders, Circadian Rhythm

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Groups/Cohorts
Prospective cohort study
Observational only

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will include elderly patients admitted to the intensive care unit at UCSF.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280097

Contacts
Contact: Gabriela Meckler, BS 415-476-9489 mecklerg@anesthesia.ucsf.edu
Contact: Stacey Newman, BA 415-476-8612 newmans@anesthesia.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143-0648
Contact: Gabriela Meckler    415-476-9489    mecklerg@anesthesia.ucsf.edu   
Contact: Stacey Newman    415-476-8612    newmans@anesthesia.ucsf.edu   
Principal Investigator: Jacqueline M Leung, MD, MPH         
Sub-Investigator: Michael Gropper, PhD, MD         
Sub-Investigator: Mervyn Maze, MB ChB         
Sub-Investigator: Susana Vacas, MD         
Sponsors and Collaborators
University of California, San Francisco
Masimo Labs
Investigators
Principal Investigator: Jacqueline M Leung, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01280097     History of Changes
Other Study ID Numbers: 10-02079
Study First Received: January 18, 2011
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
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

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Delirium
Parasomnias
Sleep Disorders
Chronobiology Disorders
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Occupational Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014