The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.
研究概览
简要总结
This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Serous Otitis Media for More Then 3 months
- •Conductive Hearing Loss of More Then 15 decibels.
- •Tympanometry type B or C.
排除标准
- •No History of Tympanostomy Tube Insertion or Adenoidectomy
- •No Cranio or Facial Malformations
- •No Acute Upper Respiratory Tract Infection or Acute Otitis Media
结局指标
主要结局
Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.
Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.
次要结局
- Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
- Rate of referrals for tympanostomy tube insertion at 3 months