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

NCT04519489 | Terminated FDA Device

• 1 other identifier: ICBE-2-29320
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation; Obstructive Sleep Apnea

Keywords

Recurrence; Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline in atrial fibrillation burden at 6 months

  Baseline, the 6th month.

• 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.

• Changes from baseline in quality of life at 3 months and 6 months.

  Baseline, the 3rd month and 6th month.

• Changes from baseline in daytime sleepiness at 1 month, 3 months and 6 months.

  The 1st month, 3rd month and 6th month.

• Other cardiovascular events

  From baseline to the event occurs, up to 6 months.

Study Arms (2)

PAP therapy with telemonitoring

EXPERIMENTAL

This arm will consist of 86 subjects.

Device: PAP therapy with telemonitoring

Control group

OTHER

This arm will consist of 43 subjects.

Other: AF standard management and OSA general care

Interventions

PAP therapy with telemonitoring DEVICE

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.

PAP therapy with telemonitoring

AF standard management and OSA general care OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic paroxysmal or persistent atrial fibrillation:
• 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).
• Persistent: lasting over 7 days to 1 year persistent AF with ECG documented.
• Implement a rhythm control strategy, including:
• Ablation and restored on sinus rhythm after the procedure.
• Underwent medical or electrical cardioversion during hospitalization and restored on sinus rhythm before enrollment.
• OSA diagnosed with PSG test showing AHI≥10;
• ≤ 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Philips (China) Investment CO., LTD: lead
• Peking University First Hospital: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• Beijing Tongren Hospital: collaborator
• Fu Wai Hospital, Beijing, China: collaborator
• Shanghai 6th People's Hospital: collaborator
• Ruijin Hospital: collaborator

Study Sites (2)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (14)

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MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Jingying Ye, Professor

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

• Yong Huo, Professor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: August 19, 2020
• Study Start: September 18, 2020
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: September 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)