Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation
Sponsor: Beijing Anzhen Hospital • ClinicalTrials.gov ID: NCT07444372
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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. 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.
Interventions
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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.
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Usual Care
(Other)
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.
Eligibility criteria
Conditions
Locations
- Beijing Chaoyang Hospital, Capital Medical University — Beijing, Beijing Municipality, China
- Beijing Anzhen Hospital — Beijing, Beijing Municipality, China
- Beijing Jishuitan Hospital — Beijing, Beijing Municipality, China
- Beijing Hospital — Beijing, Beijing Municipality, China
- Peking University International Hospital — Beijing, Beijing Municipality, China
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China
- First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
- Zhangzhou Hospital of Fujian Province — Zhangzhou, Fujian, China
- People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China
- Langfang People's Hospital — Langfang, Hebei, China
- Shijiazhuang Great Wall Hospital of Integrated Traditional Chinese and Western Medicine — Shijiazhuang, Hebei, China
- The Ninth Hospital of Xingtai — Xingtai, Hebei, China
- Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
- Shangqiu First People's Hospital — Shangqiu, Henan, China
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
- Wuhan No. 1 Hospital — Wuhan, Hubei, China
- Wuhan Asia General Hospital — Wuhan, Hubei, China
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China
- The First Hospital of Jilin University — Changchun, Jilin, China
- First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China
- First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
- Shengli Oilfield Central Hospital — Dongying, Shandong, China
- Linyi People's Hospital — Linyi, Shandong, China
- Second Hospital of Shanxi Medical University — Taiyuan, Shanxi, China
- Tianjin Chest Hospital — Tianjin, Tianjin Municipality, China
- Yan'an Hospital of Kunming City — Kunming, Yunnan, China
- First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China
- Tianjin Medical University Second Hospital — Tianjin, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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