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Sleep and Circadian Rhythms in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01276652
First Posted: January 13, 2011
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
The Brain Research Foundation
Information provided by (Responsible Party):
University of Chicago
  Purpose
This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.

Condition Intervention Phase
Respiratory Failure Critical Illness Behavioral: Environmental modification Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Feasibility of studying sleep and circadian rhythms in acutely ill, mechanically ventilated patients. [ Time Frame: Average 2 weeks (patients followed to hospital discharge) ]
    This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients utilizing continuous bedside polysomnography and the collection of urinary samples for 6-sulfatoxymelatonin analysis.


Secondary Outcome Measures:
  • Feasibility of strengthening the day/night routine of acutely ill, mechanically ventilated patients. [ Time Frame: Average 2 weeks (patients followed to hospital discharge) ]
    A subset of subjects will be randomly assigned to receive routine care according to a classical day/night routine (rather than a 24-hour care cycle) at various points in time. The feasibility of employing additional measures to limit environmental disruption, such as the use of eyeshades and noise reduction strategies, will also be explored.


Enrollment: 25
Study Start Date: November 2001
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Environmental modification Behavioral: Environmental modification
For a subset of patients, the feasibility of delivering routine care according to classic day/night routines and of reducing exposure to environmental light and sound will be assessed.
No Intervention: Usual care

Detailed Description:
Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults undergoing mechanical ventilation in the medical intensive care unit.

Exclusion Criteria:

  • Central nervous system disease (stroke, seizure, dementia, etc)
  • Metabolic or hypoxic encephalopathy
  • Confirmed or suspected drug overdose
  • Currently receiving neuromuscular blockers
  • Coma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276652


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Heart, Lung, and Blood Institute (NHLBI)
The Brain Research Foundation
Investigators
Principal Investigator: Brian K Gehlbach, MD University of Chicago
Principal Investigator: Jesse Hall, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01276652     History of Changes
Other Study ID Numbers: SleepICU111
5K23HL088020 ( U.S. NIH Grant/Contract )
First Submitted: January 10, 2011
First Posted: January 13, 2011
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by University of Chicago:
Polysomnography
Circadian rhythmicity

Additional relevant MeSH terms:
Respiratory Insufficiency
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes


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