Atrial Fibrillation Recurrence in Sleep Apnea

This study has been completed.
Sponsor:
Collaborators:
ResMed Foundation
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00263757
First received: December 7, 2005
Last updated: July 7, 2014
Last verified: July 2014

December 7, 2005
July 7, 2014
October 2009
May 2012   (final data collection date for primary outcome measure)
Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Atrial fibrillation recurrence at 1 year
Complete list of historical versions of study NCT00263757 on ClinicalTrials.gov Archive Site
  • Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
    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).
  • Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
    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).
  • quality of life
  • ambulatory blood pressure
  • serum markers of cardiovascular disease
Not Provided
Not Provided
 
Atrial Fibrillation Recurrence in Sleep Apnea
A Randomized Trial of Positive Airway Pressure Therapy In 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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea
  • Atrial Fibrillation
  • 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.
  • Other: Usual Care
    Subjects randomized to this arm received medical management as prescribed by their cardiologist.
  • Experimental: Therapeutic Positive Airway Pressure
    Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
    Intervention: Device: Adaptive Servo-Ventilation
  • Usual Care
    Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2012
May 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00263757
1254-05, 1RC1HL099534, UL1RR024150
Yes
Sean M. Caples, D.O, Mayo Clinic
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
Mayo Clinic
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP