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: November 7, 2012
Last verified: November 2012

December 7, 2005
November 7, 2012
October 2009
May 2012   (final data collection date for primary outcome measure)
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
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • serum markers of cardiovascular disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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

The purpose of the study is to determine if, in people with sleep apnea who have undergone cardioversion therapy for atrial fibrillation, the recurrence rate of atrial fibrillation is affected by sleep apnea treatment.

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-ventilator (ASV)
Positive airway pressure therapy effectively treats obstructive and central sleep apnea.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
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 CVA, 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 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, 559-155-9900, NIH Grant
Not Provided
Sean M. Caples, D.O, Mayo Clinic
Mayo Clinic
  • National Heart, Lung, and Blood Institute (NHLBI)
  • ResMed Foundation
Principal Investigator: Sean M. Caples, D.O. Mayo Clinic
Mayo Clinic
November 2012

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