Follow-up Studies of PS and OSAHS in Chinese Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The changes of PSG parameters of children with PS or OSAS
研究概览
简要总结
The study is designed to investigate the natural course of Primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires in 6 months after treatment.
详细描述
The evolution of snoring and OSAS in children is not well established since few studies have been published.This study is designed to evaluate the evolution of primary snoring and OSAS in children who had been submitted to watchful waiting 、drug or adenotonsillectomy.The participated children will be evaluated by full physical examination and nocturnal polysomnography（PSG）, after which they were divided into 2 groups: apnea and snoring. After 6 months following the initial evaluation, patients were submitted to a new nocturnal polysomnography, and all data were compared to those of the first examination.And after 3 months and 12 months following the initial evaluation, patients will be called to complete the sleep questionnaire.Then analyse the change of parameters of polysomnography after 6 months of follow-up,and describe the changes of items of sleep questionnaire.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram.
排除标准
- •Children who are suffered from any chronic medical or psychiatric condition
- •Children with acute respiratory infection
- •Children with severe craniofacial deformities
- •Children with cardiopulmonary diseases
- •Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate
结局指标
主要结局
The changes of PSG parameters of children with PS or OSAS
时间窗: 6 months
In our study, there are 55 children of mild to moderate SDB with conservative treatment, among which 23 children are chosen in PS group and 32 children are chosen in OSAS group. For PSG, according to the value of OAHI to determine the improvement of the child, the value of OAHI is decreased by ≥ 25% for improvement. In the PS group, there were 2 cases with improvement, and the corresponding remission rate was 8.7%. In the OSAS group, there are 22 cases with improvement, and the corresponding remission rate was 68.8%. There was a significant difference between the remission rate of PS group and that of OSAS group (P\<0.001).
次要结局
- The high-sensitivity CRP and Heart rate variability (HRV) of children with SDB(0 months)
- The changes of sleep questionnaires of children with PS or OSAS(3 months, 6 months, 12 months)
- The changes of level of leukotriene in urine of children with PS or OSAS(6 months)
研究者
Zhifei Xu
The chief of Sleep center
Beijing Children's Hospital