Heart Hole Closure for Obstructive Sleep Apnea

Overseen By Eduardo de Marchena, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether closing a small hole in the heart, known as a patent foramen ovale (PFO), can benefit people with obstructive sleep apnea (OSA) who continue to experience low oxygen levels at night despite receiving the best available treatment. The trial focuses on individuals with severe OSA, characterized by frequent pauses in breathing or shallow breathing during sleep. Suitable candidates should have a diagnosis of severe OSA and a PFO, detectable through a heart ultrasound. As an unphased trial, this study provides a unique opportunity to explore new treatment possibilities for those with severe OSA and PFO.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, you must be able to take aspirin, clopidogrel, or ticagrelor to participate.

What prior data suggests that PFO closure is safe for patients with obstructive sleep apnea?

Previous studies have found that closing a PFO (a small hole in the heart) is generally safe. For example, one study showed that the procedure succeeded for all patients without immediate problems. However, about 1.39% of patients developed a new irregular heartbeat, called atrial fibrillation, which usually appeared later.

Another study found that closing a PFO improved breathing and oxygen levels at night for people with obstructive sleep apnea (OSA). These improvements can lead to better heart and blood vessel health.

Overall, while closing a PFO is usually well-tolerated, there is a small risk of changes in heart rhythm later on. These findings are important to consider when thinking about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PFO closure for obstructive sleep apnea because it offers a novel approach by addressing a structural issue in the heart. Unlike standard treatments like CPAP machines or oral appliances that focus on managing symptoms, PFO closure aims to eliminate a potential underlying cause of sleep apnea by closing a small hole in the heart called a Patent Foramen Ovale (PFO). This could potentially lead to more significant and lasting improvements in sleep quality and overall health by targeting the root of the problem rather than just alleviating the symptoms.

What evidence suggests that PFO closure might be an effective treatment for obstructive sleep apnea?

Research has shown that closing a small hole in the heart, known as a patent foramen ovale (PFO), can benefit people with obstructive sleep apnea (OSA). Some studies found that closing this hole improves breathing during sleep and increases oxygen levels at night. This improvement may enhance blood vessel function and overall heart health. In past cases, patients reported benefits such as reduced shortness of breath during exercise. The procedure is generally safe, with a low risk of complications. Overall, closing a PFO appears promising for enhancing sleep and heart health in people with OSA. Participants in this trial will undergo PFO closure and will be monitored until repeat sleep apnea testing, up to 6 months. ^{1 2 3 6 7}

Who Is on the Research Team?

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?

Group I: Persistent hypoxemia after Obstructive sleep apnea group Experimental Treatment 1 Intervention

Participants will receive Patent Foramen Ovale (PFO) closure and followed until repeat sleep apnea testing up to 6 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5991552/

Patent Foramen Ovale in Severe Obstructive Sleep Apnea Data on the effect of PFO closure in OSA are limited to one case report, which documented a resolution of exercise-induced dyspnea. An improvement in OSA ...

2. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.115.06303

Patent Foramen Ovale Closure in Obstructive Sleep Apnea ... PFO closure in OSA patients improves sleep-disordered breathing and nocturnal oxygenation. This translates into an improvement of endothelial function and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058981325000165

Long-term outcomes following patent foramen ovale device ... PFO closure was successful in all patients without complications. New onset atrial fibrillation (AF) occurred in 6 patients (1.39 %), typically later during ...

4. frontiersin.org frontiersin.org/journals/stroke/articles/10.3389/fstro.2022.916154/full

Obstructive Sleep Apnea (OSA) and Patent Foramen Ovale ... Her PFO was closed 4 months later. Six months post-stroke, a home sleep study showed severe OSA with AHI of 36.3, worse in REM sleep with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10531865/

Clinical Outcomes and Quality of Life after Patent Foramen ... The data collected in this study demonstrate that percutaneous PFO closure is a safe and effective procedure both in patients with previous stroke/TIA of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02771561?term=closure%20patent%20foramen%20ovale&viewType=Table&rank=10

NCT02771561 | PFO Closure for Obstructive Sleep Apnoea OSA is associated with an increased risk of heart disease and stroke. In some individuals, the low oxygen levels in the blood can be made worse by also having ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2017.09.345

TCT-268 Patent Foramen Ovale Closure to treat ... Although PFO closure is safe and effective it did not improve respiratory polygraphy measures of OSA severity and therefore should not be ...