The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Actigraphy measurements
研究概览
简要总结
The purpose of this study is to investigate the prevalence of sleep disturbances in children with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion (TTI) on sleep disturbances.
详细描述
Comparison of sleep disturbances will be between infants with Chronic Otitis Media with Effusion (COME) who will be referred for tympanostomy tube insertion (TTI) (study group) and healthy infants that were recruited from the community well-baby clinics (control group).
To evaluate sleep patterns, parents of the study group will complete two validated sleep questionnaires assessing the infant's typical sleep patterns based on parental reports. A week before TTI and 1 week to 1 month after the surgery, sleep will be evaluate by actigraph for a week long.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6-36 months
- •Referred for tympanostomy tube insertion as a treatment for COME.
排除标准
- •Snoring and sleep disordered breathing (SDB)
- •Chronic medical condition
- •referred for TTI and adenoidectomy/tonsillectomy
结局指标
主要结局
Actigraphy measurements
时间窗: Up to two years
次要结局
- Brief Infant Sleep Questionnaire (BISQ) score(Up to two years)
- OSA-18 questionnaire score(Up to two years)