The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA
NCT ID: NCT04519489
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
129 participants
INTERVENTIONAL
2020-09-18
2021-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PAP therapy with telemonitoring
This arm will consist of 86 subjects.
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.
Control group
This arm will consist of 43 subjects.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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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
Philips (China) Investment CO., LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Jingying Ye, Professor
Role: PRINCIPAL_INVESTIGATOR
Beijing Tsinghua Changgeng Hospital
Yong Huo, Professor
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Yaranov DM, Smyrlis A, Usatii N, Butler A, Petrini JR, Mendez J, Warshofsky MK. Effect of obstructive sleep apnea on frequency of stroke in patients with atrial fibrillation. Am J Cardiol. 2015 Feb 15;115(4):461-5. doi: 10.1016/j.amjcard.2014.11.027. Epub 2014 Nov 29.
Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation. 2019 Jul 9;140(2):e125-e151. doi: 10.1161/CIR.0000000000000665. Epub 2019 Jan 28. No abstract available.
Li L, Wang ZW, Li J, Ge X, Guo LZ, Wang Y, Guo WH, Jiang CX, Ma CS. Efficacy of catheter ablation of atrial fibrillation in patients with obstructive sleep apnoea with and without continuous positive airway pressure treatment: a meta-analysis of observational studies. Europace. 2014 Sep;16(9):1309-14. doi: 10.1093/europace/euu066. Epub 2014 Apr 2.
Shukla A, Aizer A, Holmes D, Fowler S, Park DS, Bernstein S, Bernstein N, Chinitz L. Effect of Obstructive Sleep Apnea Treatment on Atrial Fibrillation Recurrence: A Meta-Analysis. JACC Clin Electrophysiol. 2015 Mar-Apr;1(1-2):41-51. doi: 10.1016/j.jacep.2015.02.014. Epub 2015 Apr 20.
Qureshi WT, Nasir UB, Alqalyoobi S, O'Neal WT, Mawri S, Sabbagh S, Soliman EZ, Al-Mallah MH. Meta-Analysis of Continuous Positive Airway Pressure as a Therapy of Atrial Fibrillation in Obstructive Sleep Apnea. Am J Cardiol. 2015 Dec 1;116(11):1767-73. doi: 10.1016/j.amjcard.2015.08.046. Epub 2015 Sep 12.
Nalliah CJ, Sanders P, Kalman JM. Obstructive Sleep Apnea Treatment and Atrial Fibrillation: A Need for Definitive Evidence. J Cardiovasc Electrophysiol. 2016 Aug;27(8):1001-10. doi: 10.1111/jce.12981. Epub 2016 May 31.
Craig S, Pepperell JC, Kohler M, Crosthwaite N, Davies RJ, Stradling JR. Continuous positive airway pressure treatment for obstructive sleep apnoea reduces resting heart rate but does not affect dysrhythmias: a randomised controlled trial. J Sleep Res. 2009 Sep;18(3):329-36. doi: 10.1111/j.1365-2869.2008.00726.x. Epub 2009 Jun 22.
Copur AS, Erik Everhart D, Zhang C, Chen Z, Shekhani H, Mathevosian S, Loveless J, Watson E, Kadri I, Wallace L, Simon E, Fulambarker AM. Effect of personality traits on adherence with positive airway pressure therapy in obstructive sleep apnea patients. Sleep Breath. 2018 May;22(2):369-376. doi: 10.1007/s11325-017-1559-5. Epub 2017 Aug 30.
Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D). Br J Rheumatol. 1997 May;36(5):551-9. doi: 10.1093/rheumatology/36.5.551.
Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
Kilicaslan F, Verma A, Saad E, Themistoclakis S, Bonso A, Raviele A, Bozbas H, Andrews MW, Beheiry S, Hao S, Cummings JE, Marrouche NF, Lakkireddy D, Wazni O, Yamaji H, Saenz LC, Saliba W, Schweikert RA, Natale A. Efficacy of catheter ablation of atrial fibrillation in patients with hypertrophic obstructive cardiomyopathy. Heart Rhythm. 2006 Mar;3(3):275-80. doi: 10.1016/j.hrthm.2005.11.013.
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Other Identifiers
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ICBE-2-29320
Identifier Type: -
Identifier Source: org_study_id
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