N/A
N=25
Atrial Fibrillation Recurrence in Sleep Apnea
Sleep Apnea · Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00263757 ↗Enrolled (actual)
25
Serious AEs
12.0%
Results posted
Aug 2014
Primary outcome: Primary: Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year — 3; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adaptive Servo-Ventilation (Device); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year |
3; 3 | — |
| SECONDARY Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit |
4.75; 7.31; 5.80; 5.67 | — |
| SECONDARY Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ) |
19.08; 17.62; 18.25; 17.50 | — |
Summary
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).
Eligibility Criteria
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 cerebrovascular accident (CVA), transient ischemic attack (TIA), neuromuscular disease, diaphragmatic paralysis)
- Severe cardiac disease (LVEF 2.5)
- Excessive ethanol (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).
Data sourced from ClinicalTrials.gov (NCT00263757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.