Close Obstructive Sleep Apnea (OSA) Trial

University of Miami

Status: Withdrawn

Conditions: Patent Foramen Ovale; Obstructive Sleep Apnea

Treatments: Procedure: PFO closure

Study type: Interventional

Funder types: Other

Identifiers

NCT06113562

20181090

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Persistent hypoxemia after Obstructive sleep apnea group

Experimental group

Description:

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

Treatment:

Procedure: PFO closure