Status:
WITHDRAWN
Cardiac Hemodynamics in Overlap Syndrome (COPD With Obstructive Sleep Apnea)
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Chronic Obstructive Airway Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen to asses the im...
Detailed Description
Presence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S. population. Despite the high p...
Eligibility Criteria
Inclusion
- Both men and women with age more than 18 years.
- Known diagnosis of COPD (GOLD stage 2 or higher).
Exclusion
- Already using CPAP or BPAP device.
- Estimated GFR \<30 ml/min/1.73 m2 or on hemodialysis.
- Women known to be pregnant or planning to be pregnant in next 6 months.
- Cardiac pacemaker, metallic heart valves, metallic implants, claustrophobic.
- Chronic atrial fibrillation or frequent premature ventricular contractions.
- Using lipid-lowering medications, aspirin, oral steroids, steroid-sparing medications or anti-oxidant vitamin supplements.
- If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit.
- Contraindications to stress cardiac testing: acute myocardial infarction within 48 hours, unstable angina not yet stabilized with medical therapy, ongoing chest pain, active broncho-constriction, uncontrolled cardiac arrhythmia, symptomatic severe aortic stenosis, aortic dissection, acute pulmonary embolism or pericarditis.
- Uncontrolled COPD or acute COPD exacerbation.
- Known chronic inflammatory diseases like lupus or active infection.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01261377
Start Date
November 1 2010
End Date
September 1 2011
Last Update
January 12 2017
Active Locations (2)
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1
Massachussets General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115