Atrial Fibrillation Recurrence in Sleep Apnea
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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 |
- Atrial fibrillation recurrence at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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) |
-
Device: adaptive servo-ventilator (ASV)
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 |
Inclusion criteria:
- Age >18 yrs
- Successful electrical or chemical cardioversion within previous 2 weeks
- Greater than 2 episodes symptomatic AF in previous 6 months
Exclusion criteria:
- Currently on PAP therapy
- Moderate to severe pulmonary disease
- Neurologic impairment (h/o CVA, TIA, neuromuscular disease, diaphragmatic paralysis)
- Severe cardiac disease (LVEF<40%, greater than mild to moderate valvular disease)
- Post cardiac surgery AF
- Congenital heart disease
- 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 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 May 23, 2013