WithdrawnNot Applicable

Close Obstructive Sleep Apnea (OSA) Trial

Stopped: Withdrawn (Not able to enroll patients.)

0Started 2025-02-01

Plain-language summary

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 can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Individuals unable to take aspirin, clopidogrel, and/or ticagrelor.
. Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

changes in the apnea hypoxia index

Timeframe: baseline and then up to 3 months after the study

change in mean nocturnal oxygen saturation

Timeframe: baseline and then up to 3 months after the study

change in duration of nocturnal oxygen desaturation duration.

Timeframe: baseline and then up to 3 months after the study

Trial details

NCT IDNCT06113562

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-11

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Individuals unable to take aspirin, clopidogrel, and/or ticagrelor.
. Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.

What they're measuring

changes in the apnea hypoxia index

Timeframe: baseline and then up to 3 months after the study

change in mean nocturnal oxygen saturation

Timeframe: baseline and then up to 3 months after the study

change in duration of nocturnal oxygen desaturation duration.

Timeframe: baseline and then up to 3 months after the study