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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: September 26, 2017
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
University of Chicago
Information provided by (Responsible Party):
Brian Gehlbach, University of Iowa
January 10, 2011
January 13, 2011
December 29, 2016
September 26, 2017
September 26, 2017
November 2001
December 2008   (Final data collection date for primary outcome measure)
Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours. [ Time Frame: Average 4 days (patients followed to hospital discharge) ]
This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.
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.
Complete list of historical versions of study NCT01276652 on ClinicalTrials.gov Archive Site
Subject Tolerance of the Environmental Modification Protocol [ Time Frame: Average 4 days (patients followed to hospital discharge) ]
This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects.
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 enviromental disruption, such as the use of eyeshades and noise reduction strategies, will also be explored.
  • Occurrence of REM Sleep [ Time Frame: Average 4 days (patients followed to hospital discharge) ]
    Occurrence of identifiable rapid eye movement (REM) sleep in each subject.
  • Normal Timing of 6-sulfatoxymelatonin Excretion [ Time Frame: Average 4 days (patients followed to hospital discharge) ]
    The number of participants in each group who exhibit normal timing of 6-sulfatoxymelatonin excretion will be reported. The normal timing of peak melatonin excretion was considered to be between midnight and 05:00. Subjects in whom the melatonin onset occurred after midnight or the acrophase occurred after 05:00 were considered to be phase delayed, while patients whose acrophase occurred prior to midnight were considered to be phase advanced.
Not Provided
 
Sleep and Circadian Rhythms in Mechanically Ventilated Patients
Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects were randomized in 1:1 fashion to receive the Environmental Modification protocol or usual care. Subsequently a third, observational arm was opened to acquire more physiologic data.
Masking: None (Open Label)
Primary Purpose: Other
  • Respiratory Failure
  • Critical Illness
Behavioral: Environmental modification
Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
  • Active Comparator: Environmental modification
    Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment.
    Intervention: Behavioral: Environmental modification
  • No Intervention: Usual care (randomized)
    Usual care is provided for the first 48 hours. Subsequently, in the initial protocol, subjects received 48 hours of the environmental modification intervention so long as they remained in the ICU during this time. The opportunity to receive the "Delayed" intervention was later removed from the protocol.
  • No Intervention: Usual care (observational)
    Usual care was provided.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01276652
SleepICU111
5K23HL088020 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Plan Description: As this is a pilot study, there are no plans to share IPD.
Brian Gehlbach, University of Iowa
University of Iowa
  • National Heart, Lung, and Blood Institute (NHLBI)
  • The Brain Research Foundation
  • University of Chicago
Principal Investigator: Brian K Gehlbach, MD University of Chicago
Principal Investigator: Jesse Hall, MD University of Chicago
University of Iowa
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP