A Prospective Cohort Study on Comprehensive Care of Sleep Disordered Breathing (Care-SDB Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 11,100
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
The Comprehensive Care of Sleep Disordered Breathing study (Care-SDB) is a prospective, multi-center, registry-based cohort study designed to investigate the integrated management of sleep-disordered breathing (SDB). The investigators aim to establish a nationwide SDB cohort and biobank to identify prognostic biomarkers, explore pathogenic mechanisms, and evaluate optimal treatment models. A total of 11,100 adult patients with recent sleep monitoring will be enrolled and followed longitudinally for up to 5 years. Data collection, including clinical outcomes and major adverse events, will be managed via a unified Electronic Data Capture platform. The results from Care-SDB are expected to provide critical evidence-based guidance for the risk stratification, standardized intervention, and personalized management of patients with sleep-disordered breathing.
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
- 是
入选标准
- •Age ≥ 18 years.
- •Patients who have completed sleep breathing monitoring within 1 month prior to enrollment.
- •Capable of providing signed informed consent.
排除标准
- •Estimated life expectancy of less than 3 months.
- •Refusal to participate in the study.
- •Inability to cooperate with baseline data collection or follow-up evaluations.
研究组 & 干预措施
SDB Comprehensive Management Cohort
This is a multi-center, prospective, observational registration cohort of 11,100 adult patients (age ≥ 18). All participants must have completed sleep breathing monitoring within one month prior to enrollment. The cohort aims to establish a clinical database and biobank to explore SDB-related biomarkers and pathogenesis. Participants receive comprehensive clinical management, including potential treatments for SDB, such as CPAP, oral appliances, surgery, or lifestyle interventions. Data on clinical baselines, sleep monitoring, laboratory tests, and imaging will be collected. Follow-up will be conducted for up to 5 years (at baseline, 3 months, 1 year, and annually thereafter) to evaluate clinical outcomes, including all-cause mortality and cardiovascular events.
干预措施: Clinical Management for SDB (Other)
结局指标
主要结局
All-cause mortality
时间窗: 3 and 12 months after enrollment, then annually thereafter, with a maximum follow-up duration of 5 years
次要结局
- All-cause hospitalization(Up to 5 years.)
- Comorbidity-related Adverse Events(Up to 5 years.)
- Change from Baseline in Sleep-Disordered Breathing Parameters(Baseline and up to 5 years.)
- Change in Daytime Sleepiness assessed by Epworth Sleepiness Scale (ESS)(Baseline and up to 5 years.)
- Quality of Life assessed by SF-36 Scale(Baseline and up to 5 years.)
研究者
Shao-Ping Nie
Professor of Medicine
Beijing Anzhen Hospital