Expired Study
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Iowa City, Iowa 52242


Purpose:

The goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.


Study summary:

Nearly 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This project is designed to characterize sleep and circadian rhythmicity in critically ill patients and to explore the efficacy of a non-pharmacological intervention to improve sleep and normalize circadian phase. The study will examine the effect of a protocol employing noise reduction and enforcement of a robust light-dark cycle on sleep quality and circadian rhythmicity. A secondary analysis will examine the relationship between delirium and sleep disruption and loss of circadian rhythmicity. Circadian rhythmicity will be characterized through the measurement of urinary 6-sulfatoxymelatonin levels at frequent intervals, while sleep will be assessed using continuous polysomnography.


Criteria:

Inclusion Criteria: - Age 18 years or older - Receiving mechanical ventilation and intravenous sedation Exclusion Criteria: - Debilitating central nervous system disease or degenerative disorder - Active seizures - Persistent coma - Renal failure requiring dialysis - Expected to be extubated within 24 hours - Currently receiving neuromuscular blocker


NCT ID:

NCT01284140


Primary Contact:

Principal Investigator
Brian K Gehlbach, MD
University of Iowa


Backup Contact:

N/A


Location Contact:

Iowa City, Iowa 52242
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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