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

Atrial Fibrillation Clinical Trial

— AFOSA  

Official title:

The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA: a Clinical Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04519489
• Other study ID #: ICBE-2-29320
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: March 2023

Study information

• Verified date: October 2020
• Source: Philips (China) Investment CO., LTD
• Contact: Junzeng Fu, Ph.D
• Phone: +862124127934
• Email: junzeng.fu[@]philips.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 129
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Obstructive Sleep Apnea
• Recurrence
• Sleep Apnea, Obstructive

Intervention

Device:
• PAP therapy with telemonitoring
This study intends to investigate effect of PAP therapy on reducing AF recurrence rate in the patients in co-morbidity of OSA. The study will use 2 investigational devices: Philips DreamStation and Philips EncoreAnywhere. Philips DreamStation is used as the PAP therapy device to provide PAP therapy on the study subjects; Philips EncoreAnywhere is used as a telemonitoring service to provide monitoring by physicians that ensure good adherence to PAP. In addition, subjects in the intervention group will also receive AFib standard management and OSA general care.

Other:
• AF standard management and OSA general care
Subjects in the control group will receive AF standard management and OSA general care. The treatment, medical care, and AF management for the subjects will be performed at the study hospitals following the newly updated Chinese AF management guideline 'Current knowledge and management recommendations of atrial fibrillation: 2018'.All subjects including the intervention group and the control group will receive the education materials to understand the disease, risk, and management of OSA. All subjects will also receive the general intervention for OSA, including suggestions for body weight control, smoking cessation, alcohol limiting, lateral position sleep, etc.

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing

Sponsors (7)

Lead Sponsor	Collaborator
Philips (China) Investment CO., LTD	Beijing Tongren Hospital, Beijing Tsinghua Changgung Hospital, Fu Wai Hospital, Beijing, China, Peking University First Hospital, Ruijin Hospital, Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (14)

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Li L, Wang ZW, Li J, Ge X, Guo LZ, Wang Y, Guo WH, Jiang CX, Ma CS. Efficacy of catheter ablation of atrial fibrillation in patients with obstructive sleep apnoea with and without continuous positive airway pressure treatment: a meta-analysis of observational studies. Europace. 2014 Sep;16(9):1309-14. doi: 10.1093/europace/euu066. Epub 2014 Apr 2. — View Citation

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* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with documented AFib recurrence	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).	From baseline to the event occurs, up to 6 months.
Secondary	Change from baseline in atrial fibrillation burden at 6 months	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	Baseline, the 6th month.
Secondary	Changes from baseline in self-rated AF symptoms at 1 month, 3 months and 6 months.	Self-rated AF symptoms will be tested with the modified EHRA Symptom Scale	Baseline, the 1st month, 3rd month and 6th month.
Secondary	Changes from baseline in quality of life at 3 months and 6 months.	Quality of life will be tested with EQ-5D questionnaire	Baseline, the 3rd month and 6th month.
Secondary	Changes from baseline in daytime sleepiness at 1 month, 3 months and 6 months.	Sleepiness will be tested with the Epworth Sleepiness Scale (ESS).	The 1st month, 3rd month and 6th month.
Secondary	Other cardiovascular events	Other cardiovascular events will be diagnosed and recorded by physicians.	From baseline to the event occurs, up to 6 months.