Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04519489
Other study ID # ICBE-2-29320
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 18, 2020
Est. completion date March 2023

Study information

Verified date October 2020
Source Philips (China) Investment CO., LTD
Contact Junzeng Fu, Ph.D
Phone +862124127934
Email junzeng.fu@philips.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 129
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
China Beijing Tsinghua Changgung Hospital Beijing Beijing
China Peking University First Hospital Beijing Beijing

Sponsors (7)

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

Country where clinical trial is conducted

China, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: Circulation. 2019 Aug 6;140(6):e285. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Secondary 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.
Secondary 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 Baseline, the 1st month, 3rd month and 6th month.
Secondary 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.
Secondary 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.
Secondary Other cardiovascular events Other cardiovascular events will be diagnosed and recorded by physicians. From baseline to the event occurs, up to 6 months.
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A