Heart Hole Closure for Obstructive Sleep Apnea
Ed
Overseen ByEduardo de Marchena, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
Ed
Eduardo de Marchena, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
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Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.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.
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Patent Foramen Ovale (PFO) closure and are followed until repeat sleep apnea testing
6 months
Follow-up
Participants are monitored for changes in sleep quality, physical activity, and other health measures
3 months
What Are the Treatments Tested in This Trial?
Interventions
- PFO closure
Trial Overview The 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Persistent hypoxemia after Obstructive sleep apnea groupExperimental Treatment1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Trials
976
Recruited
423,000+
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