Close Obstructive Sleep Apnea (OSA) Trial

NCT06113562 | Withdrawn DMC

• 1 other identifier: 20181090
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea; Patent Foramen Ovale

Outcome Measures

Primary Outcomes (3)

• changes in the apnea hypoxia index

  The Apnea hypopnea index that ranges from: 0 to 5 is normal 5 to15 is mild 15 to 30 is moderate greater than 30 is severe.

  baseline and then up to 3 months after the study

• change in mean nocturnal oxygen saturation

  Oxygen saturation will be measured in percentage. Ranges from 0 to 100 percent. The higher the percent the higher the oxygen saturation.

  baseline and then up to 3 months after the study

• change in duration of nocturnal oxygen desaturation duration.

  Will be measured in seconds.

  baseline and then up to 3 months after the study

Secondary Outcomes (5)

• change in quality of life as measured by the patient global impression of change scale.

  baseline and then up to 3 months after the study

• change in quality of sleep as measured by the Epworth Sleepiness Scale

  baseline and then up to 3 months after the study

• Change in physical activity as measured by Godin Leisure time physical activity questionnaire.

  baseline and then up to 3 months after the study

• change in fatigue as measured by the Fatigue Severity Scale.

  baseline and then up to 3 months after the study

• changes in functional independence measure

  baseline and then up to 3 months after the study

Study Arms (1)

Persistent hypoxemia after Obstructive sleep apnea group

EXPERIMENTAL

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

Procedure: PFO closure

Interventions

PFO closure PROCEDURE

The participants will receive a onetime closure of a small hole in heart. The procedure usually takes up to an hour. The procedure is done with local anesthesia and conscious sedation. A catheter is inserted into a vein in upper thigh and threaded to heart to deploy the closure device. Either Gore septal occluder or Amplatzer PFO occluder

Persistent hypoxemia after Obstructive sleep apnea group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Eduardo de Marchena, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and surgery

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: February 1, 2025
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share