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Obstructive sleep apnea (OSA) is a major modifiable risk factor for atrial fibrillation (AF). Continuous positive airway pressure (CPAP) therapy has been shown to improve cardiovascular outcomes; however, real-world data on its effect on AF recurrence remain limited.
This prospective cohort study aims to evaluate the association between objective CPAP adherence and the risk of AF recurrence in patients with moderate-to-severe OSA and a history of paroxysmal AF.
Patients will be followed for 12 months, with AF recurrence assessed using electrocardiography and Holter monitoring.
This is a prospective, real-world cohort study enrolling adult patients with moderate-to-severe obstructive sleep apnea (AHI ≥ 15 events/hour) and documented paroxysmal atrial fibrillation. OSA is diagnosed using home sleep apnea testing.
All participants initiate CPAP therapy, with objective adherence data collected via telemonitoring. Patients are followed for 12 months to assess AF recurrence, progression to permanent AF, and associations with CPAP usage metrics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High CPAP adherence (≥ 4 h/night) | Participants with mean nightly CPAP use ≥ 4 hours. |
| |
| Low CPAP adherence (< 4 h/night) | Participants with mean nightly CPAP use < 4 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Device | CPAP therapy is initiated according to standard clinical practice. Objective adherence data (mean nightly usage, percentage of nights ≥ 4 hours) are collected via telemonitoring systems. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Recurrence of Paroxysmal Atrial Fibrillation | First documented recurrence of paroxysmal AF confirmed by 12-lead ECG or 24-hour Holter monitoring. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression to Permanent Atrial Fibrillation | Progression to Permanent Atrial Fibrillation for 12 months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed with moderate-to-severe obstructive sleep apnea and a history of paroxysmal atrial fibrillation, managed in outpatient and hospital settings, and treated with continuous positive airway pressure therapy as part of routine clinical care.
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| Name | Affiliation | Role |
|---|---|---|
| Petar R Kalaydzhiev, PhD | Medical University - Sofia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMHAT "Tcaritca Joanna - ISUL" | Sofia | 1000 | Bulgaria |
Individual participant data will not be shared due to data protection regulations and the absence of explicit participant consent for data sharing beyond the scope of the current study.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D001281 | Atrial Fibrillation |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012138 |
| Respiratory Therapy |