Atrial Fibrillation Recurrence in Obstructive Sleep Apnea - Full Text View

Sponsors and Collaborators:	Mayo Clinic ResMed Foundation
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00263757

Purpose

The purpose of the study is to determine if, in people with obstructive 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, Obstructive Atrial Fibrillation	Device: continuous positive airway pressure (cpap)

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial Of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Obstructive Sleep Apnea

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Atrial fibrillation recurrence at 1 year

Secondary Outcome Measures:

quality of life
ambulatory blood pressure
serum markers of cardiovascular disease

Estimated Enrollment:	250
Study Start Date:	December 2005
Estimated Study Completion Date:	October 2007

Detailed Description:

Obstructive sleep apnea (OSA) is a common disorder which is increasingly implicated in the pathogenesis of cardiovascular disease. Observational data suggest that OSA 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 OSA in subjects with AF treated with DCCV. Following polysomnography, subjects with OSA 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:

Age >18 yrs
Documented atrial fibrillation or atrial flutter prior to DCCV with ECG interpreted by cardiologist.

Exclusion criteria:

Previous history of OSA or sleep study within the past 5 years that had ruled out OSA (in the absence of significant (>20 lbs) interval weight gain)
Moderate to severe pulmonary disease (FEV1 <50% predicted)—will do spirometry on smokers
Neurologic impairment (h/o CVA, TIA, neuromuscular disease, diaphragmatic paralysis)
Severe cardiac disease (LVEF<40%, greater than mild to moderate valvular disease)
Active nocturnal angina
Uncontrolled hypertension >180/110
Renal disease (Scr > 2.5)
Excessive 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263757

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sean M Caples 507-284-2495 caples.sean@mayo.edu
Principal Investigator: Sean M Caples, D.O.

Sponsors and Collaborators

Mayo Clinic

ResMed Foundation

Investigators

Principal Investigator:

Sean M. Caples, D.O.

Mayo Clinic

More Information

Study ID Numbers:	1254-05, 559-155-9900
Study First Received:	December 7, 2005
Last Updated:	January 4, 2006
ClinicalTrials.gov Identifier:	NCT00263757
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Sleep Apnea Syndromes
Heart Diseases
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Dyssomnias
Sleep Disorders

Recurrence
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009