Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

Completed

• Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea; Central Sleep Apnea

• Registration Number: NCT00922168
• Lead Sponsor: Cleveland Medical Devices Inc

Brief Summary

The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients	September 2009

Secondary Outcome Measures

Name	Time	Method
Assess Post-Operative Complications of Patients with Sleep Disordered Breathing	September 2009

Trial Locations

Locations (2)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States