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

Sponsor
Philips (China) Investment CO., LTD (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04519489
Collaborator
Peking University First Hospital (Other), Beijing Tsinghua Changgeng Hospital (Other), Beijing Tongren Hospital (Other), Fu Wai Hospital, Beijing, China (Other), Shanghai 6th People's Hospital (Other), Ruijin Hospital (Other)
129
Enrollment
2
Locations
2
Arms
29.4
Anticipated Duration (Months)
64.5
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PAP therapy with telemonitoring
  • Other: AF standard management and OSA general care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
129 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA: a Clinical Randomized Control Trial
Actual Study Start Date :
Sep 18, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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).

  5. Other cardiovascular events [From baseline to the event occurs, up to 6 months.]

    Other cardiovascular events will be diagnosed and recorded by physicians.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tsinghua Changgung Hospital Beijing Beijing China
2 Peking University First Hospital Beijing Beijing China

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jingying Ye, Professor, Beijing Tsinghua Changgeng Hospital
  • Principal Investigator: Yong Huo, Professor, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Philips (China) Investment CO., LTD
ClinicalTrials.gov Identifier:
NCT04519489
Other Study ID Numbers:
  • ICBE-2-29320
First Posted:
Aug 19, 2020
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Philips (China) Investment CO., LTD
Recurrence
Positive Airway Pressure
Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Atrial Fibrillation
Recurrence

Study Results

No Results Posted as of Oct 27, 2020