Obstructive Sleep ApneaSTOP-AFibNCT07444372
Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation
A study testing Continuous Positive Airway Pressure (CPAP) in people with Obstructive Sleep Apnea and Sleep Disorder (Disorder), run by Beijing Anzhen Hospital at 30 sites in China.
Trial summary
Atrial fibrillation (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Disorder (Disorder), Atrial Fibrillation (AF)
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 30 sitesChina
- Study dates
- 12 May 2026to 31 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following conditions to be eligible for the study:
- Age 18-75 years.
- Patients with persistent AF who received catheter ablation for the first time.
- Diagnosed with OSA.
- Able to tolerate CPAP therapy.
- Capable of understanding and complying with the study protocol.
- Willing to sign the informed consent form.
Who cannot join
- Patients meeting any of the following criteria will be excluded from the study:
- Secondary AF.
- Left atrial anteroposterior diameter 60mm (measured via parasternal long-axis view).
- Left ventricular ejection fraction < 30%.
- Comorbid moderate-to-severe mitral stenosis or history of prosthetic valve replacement (mechanical or bioprosthetic).
- Pregnant or breastfeeding women.
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- History of myocardial infarction, percutaneous coronary intervention, or cardiac surgery within 3 months prior to screening.
- History of stroke or transient ischemic attack within 6 months prior to screening.
- Perioperative complications related to the ablation procedure occurring prior to randomization.
- Inability to discontinue antiarrhythmic drugs (AADs) post-procedure due to other reasons.
- Life expectancy < 1 year.
- Central sleep apnea.
- Conditions requiring ventilatory support, including obesity hypoventilation syndrome (defined as BMI > 30kg/m² and awake PaCO₂ > 45mmHg), amyotrophic lateral sclerosis, or chronic obstructive pulmonary disease with > 1 episode of respiratory failure or hypercapnia.
- Treatment-emergent central sleep apnea during CPAP tolerance assessment that cannot be corrected prior to randomization.
- Receipt of instrumental or surgical treatment for OSA within 3 months prior to screening, including CPAP, oral appliances, ENT surgery, or bariatric surgery.
- Use of glucagon-like peptide-1 receptor agonists, glucose-dependent insulinotropic peptide receptor agonists, or glucagon receptor agonists for weight loss within 3 months prior to screening, or plans to initiate such medications within the next year.
- Current participation in other drug or device trials.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Not yet recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Zhiling Zhao, Professor, +86-10-85231000, cysleep@163.com
Zhiling Zhao, Professor
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Jiang Xie, Professor, +86 64456360, frank782008@aliyun.com
Jiang Xie, Professor
- Not yet recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Yang Cheng, Professor, +86 01058516688, hengyang0323@outlook.com
Yang Cheng, Professor
- Not yet recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Wei Gong, Professor, +86 85132266, gongwei5180@bjhmoh.cn
Wei Gong, Professor
- Not yet recruiting
Peking University International Hospital
Beijing, Beijing Municipality, 102206
Yanwen Jiang, Professor, +86 01069006163, jiangyanwen@pkuih.edu.cn
Yanwen Jiang, Professor
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Haibo Yuan, Professor, +86-431-88782222, hyuan@jlu.edu.cn
Haibo Yuan, Professor
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Ruoyun Ouyang, Professor, +86-731-85295888, ouyangruoyun@csu.edu.cn
Ruoyun Ouyang, Professor
- Not yet recruiting
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Haiying Tang, Professor, +86 0411836359632561, doctortanghy@163.com
Haiying Tang, Professor
- Not yet recruiting
Shengli Oilfield Central Hospital
Dongying, Shandong, 257034
Xiangfei Liu, Professor, +86-546-8551222, zhaoyang20023903@126.com
Xiangfei Liu, Professor
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Xiangqi Chen, Professor, +86-591-83357896, chxqq2003@126.com
Xiangqi Chen, Professor
- Not yet recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Ningfang Lian, Professor, +86 059187981698, 1533532863@qq.com
Ningfang Lian, Professor
- Not yet recruiting
Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Wei Meng, Professor, +86 045186296870, mengweixq@163.com
Wei Meng, Professor
- Not yet recruiting
Yan'an Hospital of Kunming City
Kunming, Yunnan
Xia Jiang, Professor, +86-0871-63211073, 378972370@qq.com
Xia Jiang, Professor
- Not yet recruiting
Langfang People's Hospital
Langfang, Hebei, 065000
Zengming Xue, Professor, +86 03162369665, xuezengming@163.com
Zengming Xue, Professor
- Not yet recruiting
Linyi People's Hospital
Linyi, Shandong, 276003
Li Wei, Professor, +86-539-8216261, weilineu@163.com
Li Wei, Professor
- Not yet recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Ning Ding, Professor, +86 02568307346, dingning@njmu.edu.cn
Ning Ding, Professor
- Not yet recruiting
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Mingming Zhao, Professor, +86-771-2186076, topabigale@163.com
Mingming Zhao, Professor
- Not yet recruiting
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Maoqing Tong, Professor, +86 57487085588, ganbaursy@163.com
Maoqing Tong, Professor
- Not yet recruiting
Shangqiu First People's Hospital
Shangqiu, Henan
Renshan Niu, Professor, +86-0370-3255630, niurenshan1965@163.com
Renshan Niu, Professor
- Not yet recruiting
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Wenyang Li, Professor, +86 83282530, 20122043@cmu.edu.cn
Wenyang Li, Professor
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Li Xiao, Professor, +86-24-96615, xiaolisy@163.com
Li Xiao, Professor
- Recruiting
Shijiazhuang Great Wall Hospital of Integrated Traditional Chinese and Western Medicine
Shijiazhuang, Hebei, 050000
Linyi Huang, Professor, +86-0311-85837801, 496777551@qq.com
Linyi Huang, Professor
- Not yet recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Xiaoling Gao, Professor, +86 03513362858, yihexiyuan@qq.com
Xiaoling Gao, Professor
- Not yet recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
Fang Zhao, Professor, +86-22-88185111, zfangdoctortjxkyy@163.com
Fang Zhao, Professor
- Not yet recruiting
Tianjin Medical University Second Hospital
Tianjin
Xiaoyun Zhao, Professor, +86-022-88326681, zxydoctor@163.com
Xiaoyun Zhao, Professor
- Not yet recruiting
Wuhan No. 1 Hospital
Wuhan, Hubei, 430014
Zhihua Yu, Professor, +86 02785332144, whyu027@163.com
Zhihua Yu, Professor
- Not yet recruiting
Wuhan Asia General Hospital
Wuhan, Hubei, 430056
Ning Man, Professor, +86-027-84788999, Mannyl75@126.com
Ning Man, Professor
- Recruiting
The Ninth Hospital of Xingtai
Xingtai, Hebei, 055250
Zhanwei Liu, Professor, +86-0319-4321827, liuzhanweidf@sina.com
Zhanwei Liu, Professor
- Not yet recruiting
Zhangzhou Hospital of Fujian Province
Zhangzhou, Fujian, 363000
Li Lin, Professor, +86-596-2082000, linlid222@163.com
Li Lin, Professor
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Gangqiong Liu, +86-371-66913114, doctorliu61352@163.com
Gangqiong Liu, Professor
About this study
Official title: Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation: A Multicenter, Open-label, Randomized Clinical Trial
Atrial fibrillation (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Previous studies have established a strong association between obstructive sleep apnea (OSA) and the risk of AF recurrence following ablation. While continuous positive airway pressure (CPAP) is the standard intervention for OSA, and some observational studies suggest it may reduce post-ablation recurrence in patients with comorbid OSA, small randomized controlled trials have failed to confirm a clear benefit, potentially due to poor adherence.
This study aims to evaluate the clinical benefit of post-ablation CPAP therapy in AF patients with comorbid OSA.
Read more
Participants will:
- Be randomly assigned to either the CPAP group or the usual care group.
- If in the CPAP group, use a CPAP device for 12 months.
- Wear an ambulatory ECG recorder for a 7-day period at 3, 6, 9, and 12 months after randomization.
- Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after randomization.
Read the detailed description
Atrial fibrillation (AF) is a common sustained cardiac arrhythmia, with recurrence rates of 20-45% after catheter ablation. Obstructive sleep apnea (OSA) is a common comorbidity and an important modifiable risk factor for post-ablation AF recurrence. Continuous positive airway pressure (CPAP) is the standard therapy for OSA, but its effect on reducing AF recurrence after ablation remains uncertain.This study aims to evaluate whether, in patients with OSA and AF who undergo catheter ablation, the postoperative CPAP treatment can increase the rate of no recurrence of atrial arrhythmia within one year compared to usual treatment. This prospective, multicenter, open-label, parallel-group randomized controlled trial will be conducted at approximately 20 centers in mainland China. Approximately 658 adults aged 18-75 years with persistent AF and diagnosed OSA who have successfully undergone first-time catheter ablation will be enrolled.
After confirmation of eligibility and informed consent, participants will be randomized in a 1:1 ratio to receive either CPAP therapy plus usual care or usual care alone. CPAP therapy will be provided for 12 months, with treatment parameters determined by pressure titration, and adherence monitored using device-recorded data. Participants in the usual care group will receive standard AF management and standardized education regarding OSA; additional OSA treatments outside the study protocol will be permitted and documented.All participants will receive guideline-directed medical therapy for AF.
Follow-up will last at least 12 months, with assessments at approximately 1, 3, 6, and 12 months after randomization. Atrial arrhythmia monitoring will be performed primarily using ambulatory ECG recorders.
The primary outcome is freedom from atrial arrhythmia recurrence within 12 months after randomization. Secondary outcomes include atrial arrhythmia recurrence patterns, arrhythmia-related interventions, atrial fibrillation burden, and changes in quality-of-life and psychological assessment scores.
- Conditions
- Obstructive Sleep Apnea, Sleep Disorder (Disorder), Atrial Fibrillation (AF), Sleep Disordered Breathing (SDB), Arrhythmia, Continuous Positive Airway Pressure
- Being tested
- Continuous Positive Airway Pressure (CPAP), Usual Care
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Atrial Fibrillation, Ablation of atrial fibrillation, Sleep Disordered Breathing, Clinical Trial, Catheter Ablation
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Wake Disorders, Atrial Fibrillation, Sleep Apnea Syndromes, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
Participants receive CPAP therapy provided by the research team. Treatment parameters are determined following auto-titrating or manual pressure titration. Prior to treatment initiation, participants receive training on device usage, mask fitting and adjustment, equipment cleaning and maintenance, and data transmission methods. Study physicians and technicians provide support to address any CPAP-related discomfort. 'Good adherence' is defined as device usage of ≥ 4 hours per night on ≥ 70% of days.
Usual CareOther
Participants receive standardized medical therapy for atrial fibrillation in accordance with international guidelines and clinical routine. For OSA management, researchers provide standardized health education. This includes informing participants about the risks associated with OSA and advising on lifestyle modifications, including weight loss, adopting a lateral sleeping position, and avoiding alcohol and sedatives.
| Study group | Role | What they receive |
|---|---|---|
| CPAP Group | Experimental | Usual care combined with CPAP therapy. Receives: Device: Continuous Positive Airway Pressure (CPAP); Other: Usual Care |
| Usual Care Group | Active comparator | Standard of care for atrial fibrillation and usual care for OSA (health education). Researchers advise participants to visit sleep centers or pulmonology departments for further assessment/treatment at their own discretion, but do not intervene in their choice of OSA therapy or provide the study CPAP device. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of freedom from atrial arrhythmia recurrence.
Recurrence is defined as a composite of:
- Any documented atrial arrhythmia (AF / Atrial Tachycardia [AT] / Atrial Flutter [AFL]) lasting 30 seconds after a 3-month blanking period;
- Use of Class I or III AADs after the 3-month blanking period;
- Cardioversion performed after the 3-month blanking period;
- Repeat catheter ablation performed at any time.
Measured: Within 12 months
Secondary outcomes (10)
Incidence of any documented atrial arrhythmia (AF/AFL/AT) lasting ≥30 seconds.
Measured: Within 12 months (after a 3-month blanking period).
Incidence of documented AF lasting ≥30 seconds.
Measured: Within 12 months (after a 3-month blanking period).
Incidence of documented AT lasting ≥30 seconds.
Measured: Within 12 months (after a 3-month blanking period).
Incidence of documented AFL lasting ≥30 seconds.
Measured: Within 12 months (after a 3-month blanking period).
Proportion of patients using Class I or III antiarrhythmic drugs.
Measured: Within 12 months (after a 3-month blanking period).
Proportion of patients undergoing cardioversion.
Measured: Within 12 months (after a 3-month blanking period).
Proportion of patients undergoing repeat catheter ablation.
Measured: Within 12 months.
AF burden
Measured: Within 12 months.
Change in quality of life assessed by the Atrial Fibrillation Effect on Quality-of-Life questionnaire.
Scores range from 0 to 100, where higher scores indicate a better quality of life.
Measured: Baseline, Month 12.
Change in anxiety and depression assessed by the Hospital Anxiety and Depression Scale.
Scores for both the anxiety and depression subscales range from 0 to 21, where higher scores indicate worse anxiety and depression.
Measured: Baseline, Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start12 May 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444372
- Sponsor's protocol ID
- KS2025046
- Other IDs
- 2024ZD0529100
- Acronym
- STOP-AFib
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dretzke J, Chuchu N, Agarwal R, Herd C, Chua W, Fabritz L, Bayliss S, Kotecha D, Deeks JJ, Kirchhof P, Takwoingi Y. Predicting recurrent atrial fibrillation after catheter ablation: a systematic review of prognostic models. Europace. 2020 May 1;22(5):748-760. doi: 10.1093/europace/euaa041.
PubMed 32227238Sanchez-de-la-Torre M, Gracia-Lavedan E, Benitez ID, Sanchez-de-la-Torre A, Moncusi-Moix A, Torres G, Loffler K, Woodman R, Adams R, Labarca G, Dreyse J, Eulenburg C, Thunstrom E, Glantz H, Peker Y, Anderson C, McEvoy D, Barbe F. Adherence to CPAP Treatment and the Risk of Recurrent Cardiovascular Events: A Meta-Analysis. JAMA. 2023 Oct 3;330(13):1255-1265. doi: 10.1001/jama.2023.17465.
PubMed 37787793Caples SM, Mansukhani MP, Friedman PA, Somers VK. The impact of continuous positive airway pressure treatment on the recurrence of atrial fibrillation post cardioversion: A randomized controlled trial. Int J Cardiol. 2019 Mar 1;278:133-136. doi: 10.1016/j.ijcard.2018.11.100. Epub 2018 Nov 20.
PubMed 30522886Hunt TE, Traaen GM, Aakeroy L, Bendz C, Overland B, Akre H, Steinshamn S, Loennechen JP, Hegbom F, Broch K, Lie OH, Lyseggen E, Haugaa KH, Gullestad L, Anfinsen OG. Effect of continuous positive airway pressure therapy on recurrence of atrial fibrillation after pulmonary vein isolation in patients with obstructive sleep apnea: A randomized controlled trial. Heart Rhythm. 2022 Sep;19(9):1433-1441. doi: 10.1016/j.hrthm.2022.06.016. Epub 2022 Jun 16.
PubMed 35716856Zhou Y, Yan M, Yuan J, Wang Y, Qiao S. Continuous Positive Airway Pressure Treatment Decreases the Risk of Atrial Fibrillation Recurrence in Patients with Obstructive Sleep Apnea after Radiofrequency Ablation. Int Heart J. 2022 Jul 30;63(4):716-721. doi: 10.1536/ihj.22-129. Epub 2022 Jul 14.
PubMed 35831157Holmqvist F, Guan N, Zhu Z, Kowey PR, Allen LA, Fonarow GC, Hylek EM, Mahaffey KW, Freeman JV, Chang P, Holmes DN, Peterson ED, Piccini JP, Gersh BJ; ORBIT-AF Investigators. Impact of obstructive sleep apnea and continuous positive airway pressure therapy on outcomes in patients with atrial fibrillation-Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J. 2015 May;169(5):647-654.e2. doi: 10.1016/j.ahj.2014.12.024. Epub 2015 Feb 7.
PubMed 25965712Deng F, Raza A, Guo J. Treating obstructive sleep apnea with continuous positive airway pressure reduces risk of recurrent atrial fibrillation after catheter ablation: a meta-analysis. Sleep Med. 2018 Jun;46:5-11. doi: 10.1016/j.sleep.2018.02.013. Epub 2018 Mar 22.
PubMed 29773211de Heide J, Kock-Cordeiro DBM, Bhagwandien RE, Hoogendijk MG, van der Meer KC, Wijchers SA, Szili-Torok T, Zijlstra F, Lenzen MJ, Yap SC. Impact of undiagnosed obstructive sleep apnea on atrial fibrillation recurrence following catheter ablation (OSA-AF study). Int J Cardiol Heart Vasc. 2022 Mar 24;40:101014. doi: 10.1016/j.ijcha.2022.101014. eCollection 2022 Jun.
PubMed 35663451Minami T, Yoshizawa T, Murase K, Komasa A, Aizawa T, Yamagami S, Tanaka M, Shizuta S, Sato S, Ono K, Hirai T, Kimura T, Chin K. Associations Among Sleep Apnea, Objective or Subjective Sleep Duration, and Recurrence of Atrial Fibrillation in Patients Who Undergo Radiofrequency Catheter Ablation for Persistent Atrial Fibrillation - A Prospective Observational Study. Circ J. 2025 Jan 24;89(2):184-194. doi: 10.1253/circj.CJ-24-0537. Epub 2024 Nov 12.
PubMed 39537150Yeghiazarians Y, Jneid H, Tietjens JR, Redline S, Brown DL, El-Sherif N, Mehra R, Bozkurt B, Ndumele CE, Somers VK. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 Jul 20;144(3):e56-e67. doi: 10.1161/CIR.0000000000000988. Epub 2021 Jun 21.
PubMed 34148375