Clinical Trials

Atrial Fibrillation Recurrence in Sleep Apnea

Location:

Trial status:

Closed

Why is this study being done?

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.

Who is eligible to participate?

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).

What is involved?

We will ask you to complete a short (less than 5 minute) questionnaire to assess your risk for obstructive sleep apnea (OSA). If there is a high likelihood that you have OSA, you will be asked to undergo an overnight sleep study. This will require you to sleep for one night (about 8 PM to 6 AM) in the General Clinical Research Center (GCRC) at Saint Mary?s Hospital.

This sleep study will confirm whether or not you have OSA. If you do not have OSA, the study will end.

If you do have OSA, we will perform some other tests the day after your sleep study:

1. Questionnaires


2. Body composition measurements


3. Blood pressure measurements

You will then be assigned to one of two groups by chance (as in the flip of a coin). One group will be treated with positive airway pressure (CPAP), which is pressurized room air delivered through a mask worn over the nose while you sleep. This will be in addition to the usual treatment prescribed by your doctors. The second group will not receive any specific treatment for sleep apnea, but will continue the usual treatments prescribed by your doctors.

How long is the study?

Participants will be enrolled in this research study for up to one year.

Last updated: 11/07/2012

NCT ID:

NCT00263757