CPAP Therapy and Atrial Fibrillation Recurrence in OSA (CPAP-AF)

Effects of CPAP Therapy on Atrial Fibrillation Recurrence in Patients With Obstructive Sleep Apnea: A Prospective Cohort Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation (Paroxysmal); Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: Continuous Positive Airway Pressure (CPAP)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1000
    • UMHAT "Tcaritca Joanna - ISUL"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosed moderate-to-severe OSA
3. History of paroxysmal atrial fibrillation
4. Ability to initiate CPAP therapy
5. Written informed consent -

Exclusion Criteria:

1. Left ventricular ejection fraction < 50%
2. Permanent atrial fibrillation
3. Central sleep apnea
4. End-stage chronic kidney disease
5. Inability to obtain or tolerate CPAP therapy -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High CPAP adherence (≥ 4 h/night); Participants with mean nightly CPAP use ≥ 4 hours.	Device: Continuous Positive Airway Pressure (CPAP); 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.
Low CPAP adherence (< 4 h/night); Participants with mean nightly CPAP use < 4 hours.	Device: Continuous Positive Airway Pressure (CPAP); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression to Permanent Atrial Fibrillation	Progression to Permanent Atrial Fibrillation for 12 months	12 months

Collaborators and Investigators

• Sponsor: Medical University of Sofia
• Investigators: Principal Investigator: Petar R Kalaydzhiev, PhD, Medical University - Sofia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): November 30, 2025
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: atrial fibrillation; sleep apnea; CPAP therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Therapeutics; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure
• Other Study ID Numbers: MP18/09.08.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No