Close Obstructive Sleep Apnea (OSA) Trial

Patent Foramen Ovale Closure on Newly Diagnosed Patients with Obstructive Sleep Apnea and Refractory Hypoxia: a Pilot Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea; Patent Foramen Ovale
• Intervention / Treatment: Procedure: PFO closure

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Persistent hypoxemia after Obstructive sleep apnea group; Participants will receive Patent Foramen Ovale (PFO) closure and followed until repeat sleep apnea testing up to 6 months.	Procedure: PFO closure; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in quality of life as measured by the patient global impression of change scale.	Change Scale: Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.	baseline and then up to 3 months after the study
change in quality of sleep as measured by the Epworth Sleepiness Scale	Epworth Sleepiness Scale: The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.	baseline and then up to 3 months after the study
Change in physical activity as measured by Godin Leisure time physical activity questionnaire.	Self-reported leisure time physical activity as assessed by the Godin Leisure time physical activity questionnaire in all participants. Score range from 0 upwards, with higher scores indicating more leisure time physical activity.	baseline and then up to 3 months after the study
change in fatigue as measured by the Fatigue Severity Scale.	Each item is scored between 1 and 7 (1 = strongly disagree, 7 = totally agree) in the scale consisting of 9 items that can be applied by individuals in a simple way. The total score range of the scale is 9-63. The total score is calculated by taking the average of 9 items. Accordingly, the lowest average score to be obtained is 1, and the highest average score is 7. The cut-off value was set at 4 and above to diagnose pathological fatigue. The lower the total score, the less fatigue.	baseline and then up to 3 months after the study
changes in functional independence measure	The Functional independence measure (FIM) is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition). Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.	baseline and then up to 3 months after the study

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Eduardo de Marchena, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Cardiovascular Diseases; Heart Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Congenital Abnormalities; Signs and Symptoms, Respiratory; Cardiovascular Abnormalities; Heart Defects, Congenital; Sleep Disorders, Intrinsic; Dyssomnias; Heart Septal Defects, Atrial; Heart Septal Defects; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Foramen Ovale, Patent
• Other Study ID Numbers: 20181090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No