Atrial Fibrillation Recurrence in Sleep Apnea

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-05-31

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).

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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.

Conditions

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Sleep Apnea Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapeutic Positive Airway Pressure

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

Group Type EXPERIMENTAL

Adaptive Servo-Ventilation

Intervention Type DEVICE

Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.

Usual Care

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

Group Type OTHER

Usual Care

Intervention Type OTHER

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

Interventions

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Adaptive Servo-Ventilation

Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.

Intervention Type DEVICE

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No