Close Obstructive Sleep Apnea (OSA) Trial

Study Overview
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Brief Summary
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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.

Official Title
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Patent Foramen Ovale Closure on Newly Diagnosed Patients With Obstructive Sleep Apnea and Refractory Hypoxia: A Pilot Study

Conditions
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Obstructive Sleep Apnea, Patent Foramen Ovale

Intervention / Treatment
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* Procedure: PFO closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |