Belgian Central Sleep Apnea REgistry (B-CARE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 14
- 主要终点
- Treatment choice
研究概览
简要总结
This study evaluates different factors that determine the treatment choice and treatment compliance in patients with central sleep apnea. All patients will receive routine care (registry).
详细描述
Central sleep apnea (CSA) is characterized by intermittent cessation or decrease of airflow and effort of breathing during sleep. The diagnostic criteria for CSA varies according to the type of CSA (e.g. CSA due to cardiac failure, due to a medication, ...).
CSA is defined as: (1) an apnea/hypopnea index ≥ 15 per hour of sleep and (2) the number of central apneas and/or hypopneas is > 50% of the total number of apneas and hypopneas.
Presence of CSA is associated with excessive daytime sleepiness and poor sleep quality. Furthermore, in patients with heart failure, presence of CSA was found to be related to mortality. As yet, however, there is insufficient knowledge on the clinical features, pathophysiological background and consecutive algorithms for treatment. Currently, it is not fully clear whether CSA or the treatment of CSA is related to disease progress.
The aim of this trial is to evaluate the current treatment choices for CSA in Belgium and compliance with and effects of these treatments.
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 old
- •An apnea/hypopnea index ≥ 15/h of sleep and proportion of non-obstructive events > 50%, derived from polysomnography (diagnostic or during (PAP) treatment)
- •Written informed consent provided
排除标准
- •Patients with mental disability making it impossible to understand the study protocol
结局指标
主要结局
Treatment choice
时间窗: 5 years
Proportion of patients treated with the different treatment modalities
次要结局
- Pitssburgh Sleep Quality index(5 years)
- Mortality(5 years)
- Treatment compliance(5 years)
- Short Form 36 Health Survey(5 years)
- Factors determining treatment choice(5 years)