Clinical trial NCT00263757: Atrial Fibrillation Recurrence in Sleep Apnea
Official title: A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Center for Research Resources (NCRR)
name: ResMed Foundation
First posted: 2005-12-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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 cerebrovascular accident (CVA), transient ischemic attack (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 ethanol (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).

Primary outcomes:
measure: Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit
timeFrame: baseline, 12 months
measure: Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sean M. Caples, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caples SM, Mansukhani MP, Friedman PA, Somers VK. The impact of continuous positive airway pressure treatment on the recurrence of atrial fibrillation post cardioversion: A randomized controlled trial. Int J Cardiol. 2019 Mar 1;278:133-136. doi: 10.1016/j.ijcard.2018.11.100. Epub 2018 Nov 20.