Trial Summary
What is the purpose of this trial?
The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.
Research Team
Ed
Eduardo de Marchena, MD
Principal Investigator
University of Miami
Eligibility Criteria
This trial is for people with severe obstructive sleep apnea (OSA) who still have low oxygen levels at night even after the best standard treatments. They must also have a heart condition called patent foramen ovale (PFO), confirmed by a special heart ultrasound.Inclusion Criteria
I have severe sleep apnea with an AHI over 30 and low oxygen levels at night.
My heart has a hole between its upper chambers, confirmed by an echo.
Exclusion Criteria
Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
You are not able to take aspirin, clopidogrel, or ticagrelor.
Treatment Details
Interventions
- PFO closure (Procedure)
Trial OverviewThe study is testing if closing the PFO in the heart can help improve OSA symptoms and nighttime oxygen levels in patients who haven't gotten better with usual treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Persistent hypoxemia after Obstructive sleep apnea groupExperimental Treatment1 Intervention
Participants will receive Patent Foramen Ovale (PFO) closure and followed until repeat sleep apnea testing up to 6 months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Trials
976
Patients Recruited
423,000+