Atrial Fibrillation Recurrence in Sleep Apnea

Mayo Clinic

Status: Completed

Conditions: Atrial Fibrillation; Sleep Apnea

Treatments: Other: Usual Care; Device: Adaptive Servo-Ventilation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00263757

1254-05

1RC1HL099534 (U.S. NIH Grant/Contract)

UL1RR024150 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Currently on PAP therapy
2. Moderate to severe pulmonary disease
3. Neurologic impairment (h/o cerebrovascular accident (CVA), transient ischemic attack (TIA), neuromuscular disease, diaphragmatic paralysis)
4. Severe cardiac disease (LVEF<40%, greater than mild to moderate valvular disease)
5. Post cardiac surgery AF
6. Congenital heart disease
7. Renal disease (Scr > 2.5)
8. Excessive ethanol (EtOH) use (>2 drinks/day)
9. Anatomically fixed nasal obstruction (severe septal deviation, uncontrolled rhinitis)
10. History of motor vehicle or occupational accident related to sleepiness.
11. Epworth Sleepiness Scale score >18 (out of maximum score of 24).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Therapeutic Positive Airway Pressure

Experimental group

Description:

Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.

Treatment:

Device: Adaptive Servo-Ventilation

Usual Care

Other group

Description:

Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.

Treatment:

Other: Usual Care