Patent Foramen Ovale Closure on Newly Diagnosed Patients With Obstructive Sleep Apnea and Refractory Hypoxia: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Enrollment
- 60
- Primary Endpoint
- change in mean nocturnal oxygen saturation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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- •Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
Arms & Interventions
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.
Intervention: PFO closure (Procedure)
Outcomes
Primary Outcomes
change in mean nocturnal oxygen saturation
Time Frame: 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.
change in duration of nocturnal oxygen desaturation duration.
Time Frame: baseline and then up to 3 months after the study
Will be measured in seconds.
changes in the apnea hypoxia index
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Eduardo De Marchena
Professor of Medicine and surgery
University of Miami