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Stopped: Withdrawn (Not able to enroll patients.)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 range18 Years – 80 Years

SexALL

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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 Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.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

Trial details

NCT IDNCT06113562

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-11

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials