Long Term Prognosis of Taiwanese Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Death or Major adverse cardiovascular events(MACEs)
研究概览
简要总结
The purpose of this study is to explore long-term prognosis and to identify the predictors in Taiwanese OSA patients. Validation of the prediction model derived from NHIRD with the database of National Taiwan University Hospital (NTUH) sleep center is planed to determine the effects of different treatments on long-term prognosis.
详细描述
Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent hypoxia and sleep fragmentation. OSA is associated with cardiovascular morbidity and mortality, metabolic dysregulation, and neurocognitive dysfunction, which may bring worse prognosis. Continuous positive airway pressure (CPAP) is the standard treatment of OSA while the oral appliance and surgery are the alternative treatments. The differences of craniofacial features among races contributed to the race-specific presentations of OSA. Up to date, only limited studies investigated the long-term prognosis of OSA and most of them recruited Caucasians and African Americans. Moreover, most studies didn't address the impact of treatment other than CPAP on the long-term prognosis. .
National Health Insurance Research Database (NHIRD) in Taiwan enrolled 99% of whole Taiwan's population and has longer period of 10 years for follow-up, which is suitable for investigation of long-term prognosis and predictors in OSA. However, due to limited parameters for diagnosis and treatment, the results could be biased in such secondary database research. Center of Sleep Disorder in National Taiwan University Hospital (NTUH) established from 2006 has 2,600 sleep studies annually. Therefore, database and cohort from sleep center could offer the validations of the prognosis and predictors determined from NHIRD. In addition, the impact of all three treatment modalities, namely CPAP, oral appliance, and surgery, on long-term prognosis could be studied in the prospective way.
Therefore, in this project, we aimed to achieve three goals (1) To explore long-term prognosis and identify the predictors in Taiwanese OSA patients with NHIRD, where the prediction mode of prognosis was established (2). To validate the prediction model derived from NHIRD with the database of NTUH sleep center (3) To determine the effects of different treatments on long-term prognosis with prospective following NTUH sleep center cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NHIRD - >=20 y/o; OSA ICD-9-CM code: 780.51,780.53,780.57, or 327.23; coexisted with PSG procedure code: 17008B,17008A.
- •NTUH cohort - >=20 y/o; PSG AHI>5
排除标准
- •patients refusing to anticipate our study
结局指标
主要结局
Death or Major adverse cardiovascular events(MACEs)
时间窗: from 2000 to 2013, up to 13 years
MACEs includes cardiogenic death, ischemic stroke, myocardial injury or acute coronary syndrome requiring revascularization. Data from NHIRD (database screening retrospectively) and NTUH cohort (recallable history taking).
次要结局
- Cardiovascular morbidity(from 2000 to 2013, up to 13 years)
- Neurocognitive morbidity, up to 13 years(from 2000 to 2013, up to 13 years)
- Metabolic morbidity(from 2000 to 2013, up to 13 years)
- Other morbidity(from 2000 to 2013, up to 13 years)