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
  Purpose

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.


Condition Intervention
Sleep Apnea
Atrial Fibrillation
Device: adaptive servo-ventilator (ASV)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial Of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Atrial fibrillation recurrence at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 196
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: adaptive servo-ventilator (ASV)
    Positive airway pressure therapy effectively treats obstructive and central sleep apnea.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263757

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
ResMed Foundation
Investigators
Principal Investigator: Sean M. Caples, D.O. Mayo Clinic
  More Information

No publications provided

Responsible Party: Sean M. Caples, D.O, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00263757     History of Changes
Other Study ID Numbers: 1254-05, 559-155-9900, NIH Grant
Study First Received: December 7, 2005
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014