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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
Results First Submitted: December 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Respiratory Failure
Critical Illness
Intervention: Behavioral: Environmental modification

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the medical ICU at the University of Chicago between November 2001 and December 2008. Subjects were randomized to receive the environmental modification or usual care during the first 48 hours beginning the morning after enrollment. Subsequently, we enrolled 5 subjects in an observational arm (usual care).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two subjects were withdrawn by the PI after consent but prior to randomization, when they acutely developed exclusion criteria. One additional subject was withdrawn by the surrogate decision-maker prior to the initiation of the study. No data were collected on these subjects and they are not included in the results.

Reporting Groups
  Description
Randomization: Environmental Modification Group Subjects randomized to this group underwent the environmental modification intervention designed to promote strong day/night routines for 48 hours.
Randomization: Usual Care Subjects received usual care for 48 hours beginning the morning after enrollment. A subset of this group received the intervention on a pilot basis after this time period had elapsed.
Usual Care (Observational) Subjects received usual care for 48 hours beginning the morning after enrollment.

Participant Flow for 2 periods

Period 1:   Period 1: Randomization
    Randomization: Environmental Modification Group   Randomization: Usual Care   Usual Care (Observational)
STARTED   9   8   0 [1] 
COMPLETED   9   8   0 
NOT COMPLETED   0   0   0 
[1] No subjects were enrolled in this arm during Period 1.

Period 2:   Period 2: Observational
    Randomization: Environmental Modification Group   Randomization: Usual Care   Usual Care (Observational)
STARTED   9   8   5 [1] 
COMPLETED   9   8   5 
NOT COMPLETED   0   0   0 
[1] Subjects were only enrolled in the Observational arm during Period 2.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Environmental Modification Subjects received an environmental modification intervention designed to strengthen day/night routines for the first 48 hours beginning the morning after enrollment. Usual Care was provided outside of this interval. Environmental modification consisted of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
Usual Care (Randomized) Usual Care was provided for the first 48 hours.
Usual Care (Observational) Usual care was provided for the first 48 hours.
Total Total of all reporting groups

Baseline Measures
   Environmental Modification   Usual Care (Randomized)   Usual Care (Observational)   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   8   5   22 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.8  (22.7)   59.4  (16.8)   65.8  (6.0)   62.2  (17.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      5  55.6%      5  62.5%      3  60.0%      13  59.1% 
Male      4  44.4%      3  37.5%      2  40.0%      9  40.9% 
APACHE II score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 22.7  (6.6)   21.0  (8.0)   19.2  (6.5)   20.9  (7.3) 
[1] The Acute Physiology and Chronic Health Evaluation II score is designed to measure the severity of illness of patients admitted to intensive care units, with higher scores indicating patients who are more likely to die during the admission. The score is an integer score that ranges from 0 to 71 and is calculated within 24 hours of admission from the patient's age, routinely collected physiologic data, and information regarding the patient's chronic health status.


  Outcome Measures
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1.  Primary:   Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.   [ Time Frame: Average 4 days (patients followed to hospital discharge) ]

2.  Secondary:   Subject Tolerance of the Environmental Modification Protocol   [ Time Frame: Average 4 days (patients followed to hospital discharge) ]

3.  Other Pre-specified:   Occurrence of REM Sleep   [ Time Frame: Average 4 days (patients followed to hospital discharge) ]

4.  Other Pre-specified:   Normal Timing of 6-sulfatoxymelatonin Excretion   [ Time Frame: Average 4 days (patients followed to hospital discharge) ]

5.  Post-Hoc:   Presence of Normal Slow Wave Activity   [ Time Frame: Average 4 days (patients followed to hospital discharge) ]

6.  Post-Hoc:   Presence of Normal Spectral Edge Frequency 95% (SEF95) Activity   [ Time Frame: Average 4 days (patients followed to hospital discharge) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Logistical issues related to the performance of continuous bedside polysomnography may vary from institution to institution, thereby limiting the generalizability of our results where the primary outcome measure is concerned.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Brian Gehlbach, MD
Organization: University of Iowa
phone: 319-356-3603
e-mail: brian-gehlbach@uiowa.edu



Responsible Party: Brian Gehlbach, University of Iowa
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
Results First Submitted: December 29, 2016
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017