Status:
COMPLETED
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients
Lead Sponsor:
Cleveland Medical Devices Inc
Collaborating Sponsors:
National Institutes of Health (NIH)
The Cleveland Clinic
Conditions:
Sleep Disordered Breathing
Obstructive Sleep Apnea
Eligibility:
All Genders
Brief Summary
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.
Eligibility Criteria
Inclusion
- Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.
- Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.
Exclusion
- Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.
- Subjects undergoing Maze procedure for atrial fibrillation.
- Subjects unable to comply with study procedures.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00922168
Start Date
March 1 2007
End Date
August 1 2010
Last Update
February 6 2014
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195