The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA (AFOSA)

Philips

Status: Terminated

Conditions: Atrial Fibrillation; Obstructive Sleep Apnea

Treatments: Device: PAP therapy with telemonitoring; Other: AF standard management and OSA general care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04519489

ICBE-2-29320

Details and patient eligibility

About

This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive sleep apnea.

Full description

This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive sleep apnea. The study is designed as a multi-center randomized control trial, which plans to recruit 129 atrial fibrillation patients with obstructive sleep apnea (86 in the intervention group with atrial fibrillation standard care and positive airway pressure therapy, 43 in the control group with atrial fibrillation standard care but no positive airway pressure therapy). The subjects will in total visit the hospital 4 times during their 6 months follow-up period, at baseline, 1st, 3rd, and 6th month. Subjects will undergo questionnaire surveys and medical examinations at each visit. The primary objective is to compare after 6months, the clinical failure rate between the group with positive airway pressure therapy and the group with no positive airway pressure therapy.

Enrollment: 129 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic paroxysmal or persistent atrial fibrillation:

  1. Paroxysmal: at least having one episode every month for the last recent 6 months. Each episode with symptoms lasting for over 30 minutes and at least one episode is documented (≥30 seconds episode length, documented by ECG).
  2. Persistent: lasting over 7 days to 1 year persistent AF with ECG documented.

• Implement a rhythm control strategy, including:

  1. Ablation and restored on sinus rhythm after the procedure.
  2. Underwent medical or electrical cardioversion during hospitalization and restored on sinus rhythm before enrollment.

• OSA diagnosed with PSG test showing AHI≥10;

• 18 ≤ Age ≤ 75;

• Willing to participate in the study;

• Able to provide informed consent;

• Having access to smartphones and the internet, and be capable of using them.

Exclusion criteria

• BMI > 30 kg/m2;
• LVEF ≤ 40% or HF with NYHA III/ IV;
• Other atrial arrhythmias, atrial flatter;
• Myocardial infarction;
• Hypertrophic Cardiomyopathy (HCM);
• Congenital heart disease;
• A clear diagnosis with heart valve diseases (including moderate-severe mitral stenosis/ insufficiency, moderate-severe aortic stenosis/ insufficiency);
• Hyperthyroidism heart disease;
• Other acute diseases leading to temporary AF;
• In surgery perioperative period;
• Accepted other cardiothoracic surgery except for ablation;
• PSG test showing mainly central apneas (Cheyne-Stokes breathing);
• Pulmonary diseases causing dyspnea at rest or on minimal exertion;
• With other active major organ system disease that is not suitable for study participation, such as cancer, severe liver diseases, severe kidney diseases, etc.;
• With significantly impaired cognitive function, having severe problems in learning, memory, perception, and problem solving, and are unable to understand or not be competent to the informed consent;
• Having already accepted treatment to the sleep apnea syndrome;
• Having received intervention in any other trial within 30 days prior to the planned recruitment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

PAP therapy with telemonitoring

Experimental group

Description:

This arm will consist of 86 subjects.

Treatment:

Device: PAP therapy with telemonitoring

Control group

Other group

Description:

This arm will consist of 43 subjects.

Treatment:

Other: AF standard management and OSA general care