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Cardiac Hemodynamics in Overlap Syndrome (COPD With Obstructive Sleep Apnea)
Phase 1 & 2
Waitlist Available
Led By Atul Malhotra, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
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 impact of intervention on cardiac MRI and biomarkers.
Eligible Conditions
- Chronic Obstructive Pulmonary Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
3Treatment groups
Active Control
Group I: Nocturnal oxygenActive Control1 Intervention
oxygen will be provided as per standard of care.
Group II: Continuous positive airway pressureActive Control1 Intervention
The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.
Group III: Bi-level positive airway pressure (BPAP)Active Control1 Intervention
bi-level will be titrated to optimize oxygenation and ventilation.
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,669 Previous Clinical Trials
11,877,816 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,025 Previous Clinical Trials
13,413,868 Total Patients Enrolled
Atul Malhotra, MDPrincipal InvestigatorBrigham and Women's Hospital
11 Previous Clinical Trials
905 Total Patients Enrolled