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Sponsor and investigators aligned to terminate this study.
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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Beijing Tsinghua Changgeng Hospital | OTHER |
| Beijing Tongren Hospital | OTHER |
| Fu Wai Hospital, Beijing, China |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAP therapy with telemonitoring | Experimental | This arm will consist of 86 subjects. |
|
| Control group | Other | This arm will consist of 43 subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAP therapy with telemonitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline to the event occurs, up to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, the 6th month. |
| Changes from baseline in self-rated AF symptoms at 1 month, 3 months and 6 months. |
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Inclusion Criteria:
Symptomatic paroxysmal or persistent atrial fibrillation:
Implement a rhythm control strategy, including:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jingying Ye, Professor | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Yong Huo, Professor | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | China | |||
| Peking University First Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25529543 | Background | 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. | |
| 9737513 | Background | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020181 | Sleep Apnea, Obstructive |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| OTHER |
| Shanghai 6th People's Hospital | OTHER |
| Ruijin Hospital | OTHER |
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|
| AF standard management and OSA general care | Other | 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. |
|
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. | 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. | Sleepiness will be tested with the Epworth Sleepiness Scale (ESS). | The 1st month, 3rd month and 6th month. |
| Other cardiovascular events | Other cardiovascular events will be diagnosed and recorded by physicians. | From baseline to the event occurs, up to 6 months. |
| Beijing |
| Beijing Municipality |
| China |
| 30686041 | Background | 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. |
| 24696222 | Background | 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. |
| 29759338 | Background | 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. |
| 26482182 | Background | 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. |
| 27060686 | Background | 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. |
| 19549077 | Background | 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. |
| 28856525 | Background | 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. |
| 27567408 | Background | 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. |
| 9189057 | Background | 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. |
| 10507956 | Background | 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. |
| 16500298 | Background | 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. |
| 2743002 | Background | Becker PH, Sperveslage H. Organochlorines and heavy metals in herring gull (Larus argentatus) eggs and chicks from the same clutch. Bull Environ Contam Toxicol. 1989 May;42(5):721-7. doi: 10.1007/BF01700394. No abstract available. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |