Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion Treated in ENT Private Practice; a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in sleep quality
研究概览
简要总结
The goal of this clinical, randomized trial is to compare the sleeping patterns and quality of life of children with chronic otitis media with effusion (OME) with or without tympanic tubes insertion. The main questions it aims to answer are:
- Does tympanic tube insertion have an effect on sleep quality in children with chronic OME?
- Does tympanic tube insertion improve the quality of life for the children with chronic OME and their caregivers?
Participants will have their movements during sleep and number of awakenings measured by an accelerometer placed on their wrist for 7 nights before and after tympanic tube insertion. Their caregivers will answer questionnaires regarding quality of life on behalf of the child. Researchers will compare with a control group of children who also is diagnosed with chronic OME. They will also have their sleep monitored for 7 nights and their caregivers will complete quality of life questionnaires, but the will not receive a tympanic tube. However the control group will be reassessed a month after baseline, and if they still qualify for tympanic tube insertion they will undergo the same routine as the intervention group.
详细描述
Statement of intent
Background Otitis media with effusion (OME) is a common condition in the population of young children in Denmark. Sixty percent of the Danish children will experience at least one episode of OME or acute otitis media before they are 7 years old.
OME is a condition defined by non-purulent inflammation of the middle ear with serous and/or mucinous secretion why it is also known as serous otitis media. The diagnosis is most often made by a general practitioner or an ear nose-throat (ENT) specialist by otoscopy and measuring the middle ear pressure with a tympanometer. After a period of 3 months with persistent fluid in the middle ear, the treatment is usually insertion of a tympanostomy tube, also called a grommet, in the tympanic membrane. OME may be accompanied by varying degrees of non-infectious symptoms, including earaches, hearing loss and reduced quality of life.
Tympanostomy tube insertions (TTI) are also performed in children with recurring acute otitis media. The Danish Health Authority, "Sundhedsstyrelsen", has collaborated with multiple Danish ENT specialists and published a peer reviewed National Clinical Guideline (NCG) regarding TTI.
Denmark has the highest rate of tympanostomy tube insertion (TTI) in children in the world. Every year around 36.000 TTI are performed on children in Denmark. The annual incidence is 108 : 1.000 for children between 0-3 years of age and 35 : 1.000 in children between 0-15 years of age. In comparison, the annual incidence is lower than 10 : 1.000 in United Kingdom, USA and Canada. Recent studies by DØNHOF (Danish Ear-, Nose, and Throat Specialists Organization Research Group) have shown that the vast majority of TTI procedures are conducted according to the National Clinical Guidelines (NCG).
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
- Single (Outcomes Assessor)
盲法说明
questionnaires and sleep outcome measures will be assessed by masked person
入排标准
- 年龄范围
- 1 Year 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-4 years with chronic otitis media with effusion and subjective hearing loss
- •1. time ventilation tube insertion
- •At least three months with middle ear fluid in both ears before inclusion
- •ASA group 1 and 2
排除标准
- •Recurrent AOM
- •Concomitant adenoidectomy or adenotonsillectomy
- •Lip-gum-cleft anomalies or other craniofacial malformations
- •Downs syndrome
- •Existing sleep apnea
- •Asthmatic bronchitis or other chronic lung diseases like CF or other sleep disorders
- •Children with hyperkinetic syndrome
- •Present breastfeeding during night
- •Not fluent in Danish language
- •Other systemic diseases
研究组 & 干预措施
Tympanostomy tube
Insertion of tympanostomy tubes after 3 months observation for chronic otitis media with effusion (OME) according to the National guidelines in Denmark. Sleep measurements with accelerometer 7 nights before and 7 nights after intervention. Caregivers report use of paracetamol during nights with sleep measurements.
干预措施: Tympanostomy tube insertion (Device)
Control
No tympanostomy tube treatment up to 1 month after enrollment in control group. Sleep measurements with accelerometer 7 nights at time of inclusion. Caregivers report use of paracetamol during nights with sleep measurements.
After 1 month tympanic tube insertion is allowed if still chronic OME. If tympanostomy tubes are needed the children will undergo same evaluation as the intervention group.
结局指标
主要结局
Change in sleep quality
时间窗: For the intervention group: 7 nights before and 7 nights after intervention. For the control group: 7 nights at time of inclusion.
Sleep length and quality. An accelerometer is fitted on the participants and measures movement in 3 axis. The movement counts from the acclerometer will be processed by Sadeh's algorithm giving assessed minutes of total sleep, awakenings and sleep quality. The outcome will be assessed by a blinded investigator.
Change in Quality of Life
时间窗: At inclusion and up to 2 months follow up
Quality of life quantified by the validated questionnaire OM-6. 7-point Likert scale where 1 is no problem and 7 is extreme problem. The global NRS scales were 10 point scales with o = worst possible QoL and 10 = best possible QoL
次要结局
- Use of pain reliever(For the intervention group: 7 nights before and 7 nights after intervention. For the control group: 7 nights at time of inclusion.)
研究者
Preben Homøe
Professor
Zealand University Hospital