Sleep and Circadian Rhythms in Mechanically Ventilated Patients
|ClinicalTrials.gov Identifier: NCT01276652|
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure Critical Illness||Behavioral: Environmental modification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|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)|
|Official Title:||Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: Environmental modification
Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment.
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.
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276652
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Brian K Gehlbach, MD||University of Chicago|
|Principal Investigator:||Jesse Hall, MD||University of Chicago|