NCT02569749终止不适用
Sleep Apnea-Hypopnea Syndrome Screening
Arrhythmia Network Technology S.L.9 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 9
- 主要终点
- Percentage of patients with SAHS in patients with ICD or CRTD therapy
研究概览
简要总结
To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •No previous diagnosis of sleep apnea
- •Fulfilling at least one of the following:
- •Pacemaker indication
- •ICD or CRTD therapy indication
- •Heart failure and preserved LVEF (40-50%)
- •Heart failure and reduced LVEF (<40%)
- •Signed informed consent
排除标准
- •Age younger than 18 years
- •Renal hemodialysis
- •Cardiac transplant indication
- •Women who are pregnant
- •Advanced cancer
- •Enrollment in another investigational study
- •Able and willing to comply with all testing and requirements
- •Patient not suitable for inclusion due to psychiatric conditions or short life expectancy
结局指标
主要结局
Percentage of patients with SAHS in patients with ICD or CRTD therapy
时间窗: 1 month
Percentage of patients with SAHS in patients with reduced LVEF
时间窗: 1 month
Percentage of patients with SAHS in patients with pacemaker indication
时间窗: 1 month
Percentage of patients with SAHS in patients with heart failure and preserved LVEF
时间窗: 1 month
次要结局
- Percentage of patients with central sleep apnea in all groups(1 month)
- Percentage of patients with obstructive sleep apnea in all groups(1 month)
研究者
研究点 (9)
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