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

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

Interventions

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.

Sponsors & Collaborators

• Peking University First Hospital

  collaborator OTHER

• Beijing Tsinghua Changgeng Hospital

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• Fu Wai Hospital, Beijing, China

  collaborator OTHER

• Shanghai 6th People's Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Philips (China) Investment CO., LTD

  lead INDUSTRY

Principal Investigators

• Jingying Ye, Professor · Beijing Tsinghua Changgeng Hospital

• Yong Huo, Professor · Peking University First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-18

Primary Completion

2021-12-24

Completion

2021-12-24

FDA Device

Yes

Countries

• China

Study Locations