Atrial Fibrillation Recurrence in Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00263757
Recruitment Status : Completed
First Posted : December 9, 2005
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
ResMed Foundation
Information provided by:
Mayo Clinic

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Sleep Apnea Atrial Fibrillation Device: Adaptive Servo-Ventilation Other: Usual Care Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea
Study Start Date : October 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Therapeutic Positive Airway Pressure
Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
Device: 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.

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

Primary Outcome Measures :
  1. Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00263757

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
ResMed Foundation
Principal Investigator: Sean M. Caples, D.O. Mayo Clinic

Responsible Party: Sean M. Caples, D.O, Mayo Clinic Identifier: NCT00263757     History of Changes
Other Study ID Numbers: 1254-05
1RC1HL099534 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2005    Key Record Dates
Results First Posted: August 1, 2014
Last Update Posted: August 1, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Atrial Fibrillation
Sleep Apnea Syndromes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Disease Attributes