Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- obstructive apneas per hour of sleep
研究概览
简要总结
The study is designed to investigate normal polysomnographic respiratory values of Chinese healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in Chinese children and adolescents and to establish respiratory reference values for pediatric polysomnography which based on Chinese children's data.
详细描述
We plan to recruit 200 healthy, normal children and adolescents in this study, age ranging from 3 to 15 years. All of them will be invited to undergo an overnight polysomnography for at least 7h in Beijing Children's Sleep Center, meanwhile the parameters about sleep including EEG, electromyography, electrooculography, ECG, pulse oximetry arterial oxygen saturation (SpO2), chest wall and abdomen motion, oral and nasal airflow, and end-tidal PCO2 (PETCO2) will be recorded.
Based on the data we hope to give recommendation of normal PSG parameters of Chinese kids, and on this basis,to develop the diagnosis creteria for obstructive sleep apnea syndrome which will be more suitable for Chinese children conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.3 to 14-year-old children 2.from the community of China 3.healty children
排除标准
- •children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep.
- •children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia.
- •children with history of upper respiratory tract infection nearly two weeks.
- •children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery.
- •children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase.
- •children with any medical or surgicaldiseases.
- •children who have to use use sedation to maintain sleep.
- •parents or child not understand the study or do not agree to take part in.
结局指标
主要结局
obstructive apneas per hour of sleep
时间窗: 7 hours of sleep
次要结局
- minimum oxygen desaturation of sleep(7 hours of sleep)
- central apneas per hour of sleep(7 hours of sleep)
研究者
Xin Ni
Hospital director
Beijing Children's Hospital