Establishment of a Multicenter Longitudinal Cohort of Sleep With Long-term Monitoring at Home
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Incidence of Sleep Disorders and Related Diseases
研究概览
简要总结
The goal of this observational study is to explore the long-term health outcomes of sleep disorders in adults aged 18 and older, as well as to identify associated biomarkers and risk factors. The main questions it aims to answer are:
- What are the long-term health risks associated with sleep disorders, such as cognitive decline, cardiovascular diseases, or metabolic conditions?
- Are there specific biomarkers or patterns that can predict the onset or progression of sleep disorders?
Participants diagnosed with sleep disorders (e.g., insomnia, sleep apnea) or identified as healthy controls will undergo home-based sleep monitoring and complete clinical assessments at baseline and during follow-ups over a 3-year period. Biological samples, including blood and stool, will also be collected to analyze potential biomarkers. Data will be used to develop predictive models for sleep disorder risk and outcomes.
详细描述
Sleep is a vital component of overall health and well-being. However, millions of people suffer from sleep disorders, including insomnia, sleep apnea, and parasomnias, which significantly impact their quality of life and contribute to various health conditions such as cardiovascular disease, diabetes, and cognitive decline. This comprehensive observational study aims to revolutionize the understanding, diagnosis, and treatment of sleep disorders through advanced data collection, innovative technology, and cutting-edge analysis.
Study Objectives
This study focuses on building a multicenter, multidimensional clinical sample database and integrating it with big data analysis platforms to address critical gaps in sleep disorder management. Key objectives include:
- Establishing a Standardized Database: Creating a repository of clinical, biochemical, and imaging data to better understand sleep disorders and their associated conditions.
- Developing Predictive Models: Identifying biomarkers and risk factors to develop models for early diagnosis and risk prediction.
- Improving Intervention Outcomes: Evaluating the long-term effects of various interventions on sleep disorders to inform personalized treatment plans.
- Promoting Preventive Measures: Building comprehensive early warning systems for sleep disorders to prevent progression and related health issues.
Key Research Questions
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
- •Willing to voluntarily participate in the study and provide signed informed consent.
- •Gender is not restricted, and baseline age is 18 years or older.
- •Experiencing sleep disorders and capable of complying with the study procedures and tests.
排除标准
- •Diagnosed with severe mental health conditions, such as bipolar disorder, schizophrenia, or claustrophobia.
- •Suffering from infectious diseases, including tuberculosis, HIV/AIDS, or syphilis.
- •Pregnant women.
- •Experiencing acute inflammatory responses at the time of enrollment.
- •Long-term use of corticosteroids or undergoing hormone replacement therapy.
- •Determined by the researcher to be unsuitable for participation for any reason.
- •Patients with specific diseases (e.g., cardiovascular conditions) may be excluded if the study focuses on related comorbidities.
结局指标
主要结局
Incidence of Sleep Disorders and Related Diseases
时间窗: 36 months (Baseline and follow-ups at 12, 24, and 36 months)
* Measure the occurrence of sleep disorders and related diseases, including cognitive decline, cardiovascular diseases, and metabolic conditions, over the follow-up period. * Data will be collected through clinical evaluations, sleep monitoring (e.g., polysomnography, wearable devices), and laboratory analyses (e.g., blood biomarkers). * Key metrics include the development or progression of these conditions, assessed through standardized diagnostic criteria.
次要结局
未报告次要终点
研究者
Leng Yue
Associate Professor
Peking University