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

Not Applicable

• Conditions: Atrial Fibrillation; Obstructive Sleep Apnea
• Interventions: Other: AF standard management and OSA general care; Device: PAP therapy with telemonitoring

• Registration Number: NCT04519489
• Lead Sponsor: Philips (China) Investment CO., LTD

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-19
• Study Start: 2020-09-18
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-27
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	AF standard management and OSA general care	This arm will consist of 43 subjects.
PAP therapy with telemonitoring	PAP therapy with telemonitoring	This arm will consist of 86 subjects.

Primary Outcome Measures

Name	Time	Method
Number of participants with documented AFib recurrence	From baseline to the event occurs, up to 6 months.	The primary outcome is number of participants with documented clinical failure. The documented clinical failure is defined as fulfilling any one of the following situations: documented recurrence of atrial fibrillation, atrial flutter or atrial tachycardia (lasting more than 30 seconds), new prescription of antiarrhythmic drugs (class I or III), repeat ablation (for patients underwent ablation at baseline) or new ablation (for patients used antiarrhythmic drugs for rhythm control at baseline).

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in self-rated AF symptoms at 1 month, 3 months and 6 months.	Baseline, the 1st month, 3rd month and 6th month.	Self-rated AF symptoms will be tested with the modified EHRA Symptom Scale
Changes from baseline in daytime sleepiness at 1 month, 3 months and 6 months.	The 1st month, 3rd month and 6th month.	Sleepiness will be tested with the Epworth Sleepiness Scale (ESS).
Change from baseline in atrial fibrillation burden at 6 months	Baseline, the 6th month.	Atrial fibrillation burden from baseline to 6 months will be tested by single-lead ECG, calculated by total time in AF divided by the total time in sinus rhythm
Changes from baseline in quality of life at 3 months and 6 months.	Baseline, the 3rd month and 6th month.	Quality of life will be tested with EQ-5D questionnaire
Other cardiovascular events	From baseline to the event occurs, up to 6 months.	Other cardiovascular events will be diagnosed and recorded by physicians.

Trial Locations

Locations (2)

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China