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

October 26, 2020 updated by: Philips (China) Investment CO., LTD

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
      • Beijing, Beijing, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAP therapy with telemonitoring
This arm will consist of 86 subjects.
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: Control group
This arm will consist of 43 subjects.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with documented AFib recurrence
Time Frame: 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).
From baseline to the event occurs, up to 6 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips (China) Investment CO., LTD

Collaborators

Peking University First Hospital
Ruijin Hospital
Beijing Tongren Hospital
Fu Wai Hospital, Beijing, China
Shanghai 6th People's Hospital
Beijing Tsinghua Changgeng Hospital

Investigators

  • Principal Investigator: Jingying Ye, Professor, Beijing Tsinghua Changgeng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

July 6, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICBE-2-29320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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