← Back to Search

Procedure

Heart Hole Closure for Obstructive Sleep Apnea

N/A
Waitlist Available
Led By Eduardo de Marchena, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals diagnosed with severe OSA, defined as an apnea-hypopnea index (AHI) greater than 30, associated with nocturnal saturation below 90%, as determined by a sleep medicine specialist using polysomnography.
Individuals need to have a patent foramen ovale documented by echocardiography.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and then up to 3 months after the study
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate if closing a hole in the heart can help people with sleep apnea and low oxygen levels even when other treatments don't work.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from PFO closure may include discomfort or complications at the site of closure, bleeding due to required blood-thinning medications, and rare risks associated with heart procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe sleep apnea with an AHI over 30 and low oxygen levels at night.
Select...
My heart has a hole between its upper chambers, confirmed by an echo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and then up to 3 months after the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and then up to 3 months after the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in duration of nocturnal oxygen desaturation duration.
change in mean nocturnal oxygen saturation
changes in the apnea hypoxia index
Secondary study objectives
Change in physical activity as measured by Godin Leisure time physical activity questionnaire.
change in fatigue as measured by the Fatigue Severity Scale.
change in quality of life as measured by the patient global impression of change scale.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PFO closure
2016
N/A
~280

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
949 Previous Clinical Trials
428,404 Total Patients Enrolled
Eduardo de Marchena, MDPrincipal InvestigatorUniversity of Miami
~40 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top