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Withdrawn (Not able to enroll patients.)
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo de Marchena, MD | University of Miami | Principal Investigator |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |