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NCT Number: NCT00263757

Atrial Fibrillation Recurrence in Sleep Apnea

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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Key information

Conditions

Sleep Apnea Apnea Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adaptive Servo-Ventilation

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

Other

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

Primary outcomes

  1. Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year

    Time frame: 1 year

Secondary outcomes

  1. Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit

    Time frame: baseline, 12 months

    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).

  2. Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)

    Time frame: baseline, 12 months

    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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • ResMed Foundation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2005
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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