Status:
COMPLETED
Atrial Fibrillation Recurrence in Sleep Apnea
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Conditions:
Sleep Apnea
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 fibrillatio...
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 atria...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \>18 yrs
- Successful electrical or chemical cardioversion within previous 2 weeks
- Greater than 2 episodes symptomatic AF in previous 6 months
- Exclusion criteria:
- Currently on PAP therapy
- Moderate to severe pulmonary disease
- Neurologic impairment (h/o cerebrovascular accident (CVA), transient ischemic attack (TIA), neuromuscular disease, diaphragmatic paralysis)
- Severe cardiac disease (LVEF\<40%, greater than mild to moderate valvular disease)
- Post cardiac surgery AF
- Congenital heart disease
- Renal disease (Scr \> 2.5)
- Excessive ethanol (EtOH) use (\>2 drinks/day)
- Anatomically fixed nasal obstruction (severe septal deviation, uncontrolled rhinitis)
- History of motor vehicle or occupational accident related to sleepiness.
- Epworth Sleepiness Scale score \>18 (out of maximum score of 24).
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00263757
Start Date
October 1 2009
End Date
May 1 2012
Last Update
August 1 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905