Atrial Fibrillation Recurrence in Sleep Apnea

Completed · Not applicable

Conditions studied: Sleep Apnea, Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT00263757

Run by

Mayo Clinic

People needed

25

Starts

2009-10-01

Expected to finish

2012-05-01

Last updated by the study team

2014-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 yrs
• Successful electrical or chemical cardioversion within previous 2 weeks
• Greater than 2 episodes symptomatic AF in previous 6 months

You may not qualify if…

• 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).

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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