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

Primary Purpose

Atrial Fibrillation, Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PAP therapy with telemonitoring
AF standard management and OSA general care
Sponsored by
Philips (China) Investment CO., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Recurrence, Positive Airway Pressure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Tsinghua Changgung HospitalRecruiting
  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PAP therapy with telemonitoring

Control group

Arm Description

This arm will consist of 86 subjects.

This arm will consist of 43 subjects.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
Changes from baseline in quality of life at 3 months and 6 months.
Quality of life will be tested with EQ-5D questionnaire
Changes from baseline in daytime sleepiness at 1 month, 3 months and 6 months.
Sleepiness will be tested with the Epworth Sleepiness Scale (ESS).
Other cardiovascular events
Other cardiovascular events will be diagnosed and recorded by physicians.

Full Information

First Posted
July 6, 2020
Last Updated
October 26, 2020
Sponsor
Philips (China) Investment CO., LTD
Collaborators
Peking University First Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Tongren Hospital, Fu Wai Hospital, Beijing, China, Shanghai 6th People's Hospital, Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04519489
Brief Title
The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA
Acronym
AFOSA
Official Title
The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA: a Clinical Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips (China) Investment CO., LTD
Collaborators
Peking University First Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Tongren Hospital, Fu Wai Hospital, Beijing, China, Shanghai 6th People's Hospital, Ruijin Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Obstructive Sleep Apnea
Keywords
Recurrence, Positive Airway Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAP therapy with telemonitoring
Arm Type
Experimental
Arm Description
This arm will consist of 86 subjects.
Arm Title
Control group
Arm Type
Other
Arm Description
This arm will consist of 43 subjects.
Intervention Type
Device
Intervention Name(s)
PAP therapy with telemonitoring
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
AF standard management and OSA general care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with documented AFib recurrence
Description
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).
Time Frame
From baseline to the event occurs, up to 6 months.
Secondary Outcome Measure Information:
Title
Change from baseline in atrial fibrillation burden at 6 months
Description
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
Time Frame
Baseline, the 6th month.
Title
Changes from baseline in self-rated AF symptoms at 1 month, 3 months and 6 months.
Description
Self-rated AF symptoms will be tested with the modified EHRA Symptom Scale
Time Frame
Baseline, the 1st month, 3rd month and 6th month.
Title
Changes from baseline in quality of life at 3 months and 6 months.
Description
Quality of life will be tested with EQ-5D questionnaire
Time Frame
Baseline, the 3rd month and 6th month.
Title
Changes from baseline in daytime sleepiness at 1 month, 3 months and 6 months.
Description
Sleepiness will be tested with the Epworth Sleepiness Scale (ESS).
Time Frame
The 1st month, 3rd month and 6th month.
Title
Other cardiovascular events
Description
Other cardiovascular events will be diagnosed and recorded by physicians.
Time Frame
From baseline to the event occurs, up to 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junzeng Fu, Ph.D
Phone
+862124127934
Email
junzeng.fu@philips.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingying Ye, Professor
Organizational Affiliation
Beijing Tsinghua Changgeng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong Huo, Professor
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingying Ye
Email
yejingying@vip.163.com
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Huo
Email
huoyong@263.net.cn

12. IPD Sharing Statement

Plan to Share IPD
No
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The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA

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