NCT07736872招募中不适用
Screening for Obstructive Sleep Apnea-hypopnea Syndrome - for Community Populations, Patients With Specific Diseases and Special Populations
Kang Wu2 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100,000
- 试验地点
- 2
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The goal of this prospective observational study is to learn about the current prevalence of obstructive sleep apnea-hypopnea syndrome in community population, patients with specific diseases and special population from China. The main question it aims to answer is: (1) What are the prevalence and clinical characteristics of OSA in the community population, the specific disease population and the special population respectively? (2) How about the application value of each OSA screening questionnaire for different populations？Participants will all complete a screening questionnaire, and some will be selected by random sampling to complete either a polysomnography (PSG) or a portable sleep monitor (PM).
详细描述
- This is a multi-center study spans China, engaging many hospitals and research institutions. It involves community residents, patients with hypertension, COPD, and other specific diseases, as well as special populations like university teachers and students, and company employees. The study is still recruiting and 2,185 subjects have been included currently.
- This study employs rigorous randomization methods to ensure the representativeness of the sample and the reliability of the results. For community residents, cluster sampling is first applied. A random number table method is used to select several communities within the designated research area. The research team then obtains a complete list of registered residents in these communities as the sampling frame. A computer-based random number generator is utilized to randomly select target residents. Those selected are contacted by telephone for the screening questionnaire. If telephone contact fails, interviewers visit the residents' homes to conduct the survey, ensuring every selected resident has an equal chance of participation.
- For individuals categorized into OSA high - risk and low - risk groups based on the screening questionnaire, computer - based numbering and randomization are used. Specifically, the information of individuals in each group is entered into a computer system, which assigns a unique number to each individual. Random number - generation software then produces a random sequence of numbers. Individuals are selected for subsequent PSG or PM based on this sequence. This method ensures the scientific and unbiased selection of the sample.
- The sample size is determined based on OSA's expected prevalence (23.6%). To estimate the 95% confidence interval with a 5% precision level, at least 277 participants are needed for diagnostic monitoring. Considering a 30% dropout rate and an 80% response rate for the screening questionnaire, the total sample size is set at 100,000 for questionnaires and 10,000 for PSG or PM.
- Missing data will be handled through multiple imputation. The reasons for missing data are recorded, and sensitivity analyses assess its impact on results. Data checks verify that entries meet predefined rules for range and consistency, identifying and correcting anomalies promptly.
- SOPs cover all aspects of registry operations, ensuring consistency and quality in data collection and management. All questionnaires were manually entered into the electronic system. The reports of PSG or PM were manually interpreted by two professional sleep physicians. In case of disputes, a third person was invited to intervene.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form before participating in the study
- •Complete independent behaviour and cognitive abilities
- •Ability to answer the questionnaire completely and accurately
排除标准
- •Incomplete answers to the scale
- •Patients with severe diseases and acute infections or those requiring long-term home oxygen therapy
- •Patients with severe mental and psychological disorders
- •Patients with severe organ failure
- •patients with a total sleep time <240 min by PSG or PM
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: Baseline
Collected from polysomnography (PSG) or home sleep apnea testing (PM) for the diagnosis of obstructive sleep apnea (OSA). Unit of Measure: events/hour
Lowest Oxygen Saturation (Lowest SpO₂)
时间窗: Baseline
Collected from PSG or PM to evaluate nocturnal hypoxemia. Unit of Measure: %
次要结局
- Diagnostic Value of the CNCQ-OSA Questionnaire(Baseline)
- Diagnostic Value of the STOP-Bang Questionnaire(Baseline)
- Diagnostic Value of the NoSAS Score(Baseline)
研究者
Kang Wu
Dr
Guangzhou Institute of Respiratory Disease
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
To Study sleep apnea and clicial co morbidities in association with sleep apneaCTRI/2025/04/084677Datta Meghe Institute of Higher Education and Research40
招募中
不适用
Prevalence of Obstructive Sleep Apnea in Patients With Peripheral Arterial Occlusive DiseaseNCT07283289Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer295
尚未招募
不适用
Prevalence of Risk of Obstructive Sleep Apnea and its association with BMI , Neck circumference etc in Young Adults in Urban Population - An Analytical study.CTRI/2025/07/090437Shashwati Kamble152
尚未招募
不适用
A cross-sectional study to examine the number of cases of obstructive sleep apnea in patients with head and neck cancer undergoing chemotherapy and radiation therapy.CTRI/2024/07/070556AISHWARYA I202
尚未招募
不适用
Accuracy of Sleep Apnea Questionnaires in Adults: Hospital StudyCTRI/2024/08/072008Nakwa fathima sadaf50