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

Medical University of Sofia

Status: Active, not recruiting

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

Treatments: Device: Continuous Positive Airway Pressure (CPAP)

Study type: Observational

Funder types: Other

Identifiers

NCT07358429

MP18/09.08.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

Trial design

91 participants in 2 patient groups

High CPAP adherence (≥ 4 h/night)

Description:

Participants with mean nightly CPAP use ≥ 4 hours.

Treatment:

Device: Continuous Positive Airway Pressure (CPAP)

Low CPAP adherence (< 4 h/night)

Description:

Participants with mean nightly CPAP use \< 4 hours.

Treatment:

Device: Continuous Positive Airway Pressure (CPAP)