Atrial Fibrillation Recurrence in Sleep Apnea

Atrial Fibrillation Clinical Trial

Official title:

A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263757
• Other study ID #: 1254-05
• Secondary ID: 1RC1HL099534UL1R
• Status: Completed
• Phase: N/A
• First received: December 7, 2005
• Last updated: July 7, 2014
• Start date: October 2009
• Est. completion date: May 2012

Study information

• Verified date: July 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Atrial Fibrillation
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Adaptive Servo-Ventilation
Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.

Other:
• Usual Care
Subjects randomized to this arm received medical management as prescribed by their cardiologist.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI), ResMed Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year		1 year	No
Secondary	Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit	The ESS is a measure of general level of sleepiness. The ESS asks subjects to rate their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily live, although not necessarily every day. The questionnaire has 8 questions, with responses ranging from 0 (would never dose) to 3 (high chance of dozing). Therefore the total score could range from 0 (no sleepiness) to 24 (high chance of dozing).	baseline, 12 months	No
Secondary	Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)	The FOSQ is a disease-specific quality of life questionnaire to determine functional status in adults. The measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living. There are 30 items on the questionnaire consisting of 5 factor subscales. The subject rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). A higher score indicates greater difficulty or impact of sleepiness on daily living. FOSQ total score ranges from 0 (no difficulty) to 120 (extreme difficulty).	baseline, 12 months	No