Sleep Apnea Triggers of Atrial Fibrillation: N-of-1 Randomized Control Trial (SPARTA):
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Change in Average Daily AF Burden (%)
研究概览
简要总结
A pilot N-of-1 randomized controlled trial evaluating the effectiveness of a personalized CPAP intervention in reducing atrial fibrillation (AF) burden and improving AF-related quality of life in patients with moderate to severe obstructive sleep apnea (OSA).
详细描述
This pilot study investigates whether continuous positive airway pressure (CPAP) therapy reduces AF burden in patients with paroxysmal AF and moderate to severe OSA. Using an N-of-1 randomized crossover design, each participant undergoes alternating 2-week periods with and without CPAP over 3 months. Data on AF episodes are collected from implantable cardiac devices, and AF-related quality of life is assessed using the AFEQT questionnaire. The study also examines CPAP adherence and its correlation with changes in AF burden. Results will inform the design of a larger trial and address gaps in current evidence on the cardiovascular effects of sleep apnea therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age 18-85 years
- •High burden paroxysmal AF (≥1%)
- •Moderate-severe OSA (AHI ≥ 15)
- •Implanted device with atrial diagnostics
- •Enrolled in remote monitoring
排除标准
- •AF ablation <6 months
- •Valvular abnormalities
- •Excessive daytime sleepiness in safety-critical jobs
- •Plans for ablation during study
- •Non-CPAP OSA treatment
- •Recent device implantation (<6 months)
- •Central sleep apnea
研究组 & 干预措施
Alternating CPAP vs. No Treatment
Each participant undergoes alternating 2-week periods of CPAP treatment and no treatment over approximately 13 weeks. This personalized intervention evaluates changes in AF burden and quality of life, with patients serving as their own controls.
干预措施: CPAP (Device)
结局指标
主要结局
Change in Average Daily AF Burden (%)
时间窗: Up to 13 weeks (duration of each patient's participation)
Percentage change in average daily atrial fibrillation burden, measured via implantable device data, comparing CPAP and non-CPAP periods.
次要结局
- Change in Atrial Fibrillation-Related Quality of Life (AFEQT Score)(Baseline, week 4, week 8, and final visit (~13 weeks))
研究者
Mina Chung, MD
Staff of Cardiovascular Medicine
The Cleveland Clinic