Back to resultsAtrial Fibrillation Recurrence in Sleep Apnea
Primary Purpose
Sleep Apnea, Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive Servo-Ventilation
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
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<40%, greater than mild to moderate valvular disease) Post cardiac surgery AF Congenital heart disease Renal disease (Scr > 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).
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Therapeutic Positive Airway Pressure
Usual Care
Arm Description
Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Outcomes
Primary Outcome Measures
Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT00263757
First Posted
December 7, 2005
Last Updated
July 7, 2014
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR), ResMed Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00263757
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR), ResMed Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Positive Airway Pressure
Arm Type
Experimental
Arm Description
Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
Intervention Type
Device
Intervention Name(s)
Adaptive Servo-Ventilation
Intervention Description
Adaptive Servo-Ventilation provides positive expiratory airway pressure and inspiratory pressure support, which is servocontrolled based on the detection of central sleep apnea.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Subjects randomized to this arm received medical management as prescribed by their cardiologist.
Primary Outcome Measure Information:
Title
Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit
Description
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).
Time Frame
baseline, 12 months
Title
Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)
Description
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).
Time Frame
baseline, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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<40%, greater than mild to moderate valvular disease)
Post cardiac surgery AF
Congenital heart disease
Renal disease (Scr > 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean M. Caples, D.O.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30522886
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.
Results Reference
derived
Learn more about this trial
Atrial Fibrillation Recurrence in Sleep Apnea
We'll reach out to this number within 24 hrs