Close Obstructive Sleep Apnea (OSA) Trial

Not Applicable

Withdrawn

• Conditions: Patent Foramen Ovale; Obstructive Sleep Apnea
• Interventions: Procedure: PFO closure

• Registration Number: NCT06113562
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Status Verified: 2025-02
• Study Start: 2025-02-01
• Primary Completion: 2025-02-11
• Study Completion: 2025-02-11
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

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 Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Persistent hypoxemia after Obstructive sleep apnea group	PFO closure	Participants will receive Patent Foramen Ovale (PFO) closure and followed until repeat sleep apnea testing up to 6 months.

Primary Outcome Measures

Name	Time	Method
change in duration of nocturnal oxygen desaturation duration.	baseline and then up to 3 months after the study	Will be measured in seconds.
changes in the apnea hypoxia index	baseline and then up to 3 months after the study	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.
change in mean nocturnal oxygen saturation	baseline and then up to 3 months after the study	Oxygen saturation will be measured in percentage. Ranges from 0 to 100 percent. The higher the percent the higher the oxygen saturation.

Secondary Outcome Measures

Name	Time	Method
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 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.
change in quality of sleep as measured by the Epworth Sleepiness Scale	baseline and then up to 3 months after the study	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.
Change in physical activity as measured by Godin Leisure time physical activity questionnaire.	baseline and then up to 3 months after the study	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.
change in fatigue as measured by the Fatigue Severity Scale.	baseline and then up to 3 months after the study	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.
changes in functional independence measure	baseline and then up to 3 months after the study	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States