A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year
Study Overview
Brief Summary
This randomized, controlled trial is designed to test whether treatment of sleep disordered breathing (SDB) with positive airway pressure (PAP) therapy alters the natural history of atrial fibrillation (AF). Patients with recent AF who are now in sinus rhythm, and found to have SDB (obstructive and/or central sleep apnea) by formal sleep study but without complaints of daytime sleepiness, are randomized to PAP therapy to eradicate SDB or to usual care (medical management as prescribed by the patient's cardiologist).
Detailed Description
Sleep apnea is a common disorder which is increasingly implicated in the pathogenesis of cardiovascular disease. Observational data suggest that sleep apnea may play a role in the development of atrial fibrillation (AF), and may even predispose to recurrence of AF following electrical cardioversion (DCCV). Because of biases and confounders inherent to observational studies, we propose a randomized clinical trial to assess the effects of treatment of sleep apnea in subjects with AF treated with DCCV. Following polysomnography, subjects with sleep apnea will be randomized to positive airway pressure (PAP) or usual medical care and followed for up to one year to compare a primary outcome of AF recurrence rate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year
Time Frame: 1 year
Secondary Outcomes
- Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)(baseline, 12 months)
- Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit(baseline, 12 months)