Atrial Fibrillation Recurrence in Sleep Apnea
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| ClinicalTrials.gov Identifier: NCT00263757 |
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Recruitment Status :
Completed
First Posted : December 9, 2005
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
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Sponsor:
Mayo Clinic
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
ResMed Foundation
Information provided by:
Mayo Clinic
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sleep Apnea Atrial Fibrillation | Device: Adaptive Servo-Ventilation Other: Usual Care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 25 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea |
| Study Start Date : | October 2009 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Familial atrial fibrillation
| Arm | Intervention/treatment |
|---|---|
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Experimental: Therapeutic Positive Airway Pressure
Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
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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. |
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Usual Care
Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
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Other: Usual Care
Subjects randomized to this arm received medical management as prescribed by their cardiologist. |
Primary Outcome Measures :
- Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year [ Time Frame: 1 year ]
Secondary Outcome Measures :
- Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit [ Time Frame: baseline, 12 months ]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) [ Time Frame: baseline, 12 months ]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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263757
Locations
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
ResMed Foundation
Investigators
| Principal Investigator: | Sean M. Caples, D.O. | Mayo Clinic |
| Responsible Party: | Sean M. Caples, D.O, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00263757 History of Changes |
| Other Study ID Numbers: |
1254-05 1RC1HL099534 ( U.S. NIH Grant/Contract ) UL1RR024150 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 9, 2005 Key Record Dates |
| Results First Posted: | August 1, 2014 |
| Last Update Posted: | August 1, 2014 |
| Last Verified: | July 2014 |
Additional relevant MeSH terms:
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Atrial Fibrillation Apnea Sleep Apnea Syndromes Recurrence Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Disease Attributes |