Status:
WITHDRAWN
Close Obstructive Sleep Apnea (OSA) Trial
Lead Sponsor:
University of Miami
Conditions:
Obstructive Sleep Apnea
Patent Foramen Ovale
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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- Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06113562
Start Date
February 1 2025
End Date
February 11 2025
Last Update
March 20 2025
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