NCT00638339|Completed
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Sponsor study identifier
observational
16
1 country
1
Study Start
November 2006
Actual (reported)Primary Completion
December 2013
Actual (reported)Study Completion
March 1, 2017
Actual (reported)The purpose of this study is to monitor sleep in patients using breathing machines, because little is known about sleep when patients use masks to help their breathing. We'd like to compare sleep in patients using masks to that in patients with a tube in their throats.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Actual (reported)March 12, 2008
Actual (reported)March 19, 2008
Actual (reported)December 2013
Actual (reported)March 1, 2017
Actual (reported)To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)
During 24-hour monitorization period (after recruitment into the study)
To compare total sleep time and differences in sleep architecture including time spent in different sleep stages and arousals in critically-ill patients receiving mechanical ventilation in medical ICU and CCU
During 24-hour monitorization
To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking
During 24-hour monitorization
critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU
Critically ill patients undergoing invasive or noninvasive mechanical ventilation in medical ICU and CCU at Tufts New England Medical Center
Tufts-New England Medical Center Medical ICU and Coronary Care Unit
Boston, Massachusetts, 02111, United States
Aylin Ozsancak, MD
Research Fellow
Nicholas S Hill, MD
Chair of Pulmonary, Critical Care and Sleep Medicine Division
16 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2008
First Posted
March 19, 2008
Study Start
November 2006
Actual (reported)Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns
During 24-hour monitorization
To assess associations of severity of illness and sedation usage with sleep patterns
During 24-hour monitorization period
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
March 1, 2017
Actual (reported)Last Updated
August 6, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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