Atrial Fibrillation Recurrence in Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea

Conditions
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Sleep Apnea, Atrial Fibrillation

Intervention / Treatment
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* Device: Adaptive Servo-Ventilation
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Positive Airway Pressure<br>Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months. | Device: Adaptive Servo-Ventilation<br>* Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.<br>|
| Other: Usual Care<br>Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist. | Other: Usual Care<br>* Subjects randomized to this arm received medical management as prescribed by their cardiologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit | The ESS is a measure of general level of sleepiness. The ESS asks subjects to rate their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily live, although not necessarily every day. The questionnaire has 8 questions, with responses ranging from 0 (would never dose) to 3 (high chance of dozing). Therefore the total score could range from 0 (no sleepiness) to 24 (high chance of dozing). | baseline, 12 months | 
| Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) | The FOSQ is a disease-specific quality of life questionnaire to determine functional status in adults. The measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living. There are 30 items on the questionnaire consisting of 5 factor subscales. The subject rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). A higher score indicates greater difficulty or impact of sleepiness on daily living. FOSQ total score ranges from 0 (no difficulty) to 120 (extreme difficulty). | baseline, 12 months |