CPAP Therapy and Atrial Fibrillation Recurrence in OSA

NCT07358429 | Active Not Recruiting DMC

• 1 other identifier: MP18/09.08.2024
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea (OSA); Atrial Fibrillation (Paroxysmal)

Keywords

sleep apnea; atrial fibrillation; CPAP therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression to Permanent Atrial Fibrillation

  12 months

Study Arms (2)

High CPAP adherence (≥ 4 h/night)

Participants with mean nightly CPAP use ≥ 4 hours.

Device: Continuous Positive Airway Pressure (CPAP)

Low CPAP adherence (< 4 h/night)

Participants with mean nightly CPAP use \< 4 hours.

Device: Continuous Positive Airway Pressure (CPAP)

Interventions

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.

High CPAP adherence (≥ 4 h/night); Low CPAP adherence (< 4 h/night)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Sofia: lead

Study Sites (1)

UMHAT "Tcaritca Joanna - ISUL"

Sofia, 1000, Bulgaria

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Atrial Fibrillation; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Petar R Kalaydzhiev, PhD

  Medical University - Sofia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: September 1, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)