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NCT Number: NCT07358429

CPAP Therapy and Atrial Fibrillation Recurrence in OSA

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (Paroxysmal) Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMHAT "Tcaritca Joanna - ISUL"

Sofia, 1000, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Diagnosed moderate-to-severe OSA
  • History of paroxysmal atrial fibrillation
  • Ability to initiate CPAP therapy
  • Written informed consent -

Exclusion criteria

  • Left ventricular ejection fraction < 50%
  • Permanent atrial fibrillation
  • Central sleep apnea
  • End-stage chronic kidney disease
  • Inability to obtain or tolerate CPAP therapy -

Treatment and study plan

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.

Primary outcomes

  1. Time to First Recurrence of Paroxysmal Atrial Fibrillation

    Time frame: 12 months

    First documented recurrence of paroxysmal AF confirmed by 12-lead ECG or 24-hour Holter monitoring.

Secondary outcomes

  1. Progression to Permanent Atrial Fibrillation

    Time frame: 12 months

    Progression to Permanent Atrial Fibrillation for 12 months

Sponsors and collaborators

Lead sponsor

Medical University of Sofia

Other

Registry information

Official study title

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

Acronym: CPAP-AF

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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