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NCT06113562 | NOT YET RECRUITING | Obstructive Sleep Apnea

Close Obstructive Sleep Apnea (OSA) Trial
Sponsor:

University of Miami

Information provided by (Responsible Party):

Eduardo De Marchena

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.

Condition or disease

Obstructive Sleep Apnea

Patent Foramen Ovale

Intervention/treatment

PFO closure

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Patent Foramen Ovale Closure on Newly Diagnosed Patients With Obstructive Sleep Apnea and Refractory Hypoxia: A Pilot Study
Actual Study Start Date : 2024-11-01
Estimated Primary Completion Date : 2026-08-28
Estimated Study Completion Date : 2026-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. 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.
  • 2. Individuals need to have a patent foramen ovale documented by echocardiography.
Exclusion Criteria
  • 1. Individuals unable to take aspirin, clopidogrel, and/or ticagrelor.
  • 2. Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
Close Obstructive Sleep Apnea (OSA) Trial

Location Details

NCT06113562

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

University of Miami

Miami, Florida, United States, 33136