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临床试验/NCT02315911
NCT02315911已完成不适用

Randomized Controlled Studies of Sugery for Pediatric OSA: Part 1 Expectancy Compared to Adeno-tonsillectomy for Mild-moderate OSA. Part 2 Adeno-tonsillectomy Compared to Adeno-pharyngoplasty for Severe OSA.

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
143
试验地点
1
主要终点
obstructive apnea hypopnea index

研究概览

简要总结

Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.

详细描述

Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the family is asked to be in the study. If yes, the doctor take a sealed envelope and open it, either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether PSG shows b) severe OSA and the family accept participation the child is operated within a month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2) above 30. A sealed envelope is open in the operating room by the surgeon. The child is randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded for the family, who will not know which method the child has undergone. After 6 months all children will undergo follow-up with PSG and questionnaires. If the expectancy group will deteriorate during waiting time, or the child still has moderate to severe OSA, they will undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be evaluated with two PSG, 80 in each group.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •OAHI >= 2
  • •Tonsillary hypertrophy, Brodsky size 2-4
  • •Adequate swedish knowledge

排除标准

  • •Cardiovascular disorders
  • •Pulmonary disorders
  • •Neuromuscular disorders
  • •Cranoifacial malformations
  • •Genetic disorders
  • •Earlier performed adenoid-tonsillary-surgery
  • •Bleeding disorders

研究组 & 干预措施

expectancy for mild-moderate OSA

No Intervention

6 months expectancy

ATE for mild-moderate OSA

Experimental

adeno-tonsillectomy

干预措施: ATE (Procedure)

ATE for severe OSA

Experimental

adeno-tonsillectomy

干预措施: ATE (Procedure)

APP for severe OSA

Experimental

adeno-pharyngoplasty

干预措施: APP (Procedure)

结局指标

主要结局

obstructive apnea hypopnea index

时间窗: 6 months

with full-night polysomnography

次要结局

  • postoperative pain(6 months)
  • per- and postoperative bleeding(postoperatively, weeks)
  • quality of life(6 months)
  • oxygen desaturation index(6 months)
  • Innate lymphoid cells in tonsils(6 months)
  • side-effects of surgery(6 months)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danielle Friberg

Ass professor

Karolinska University Hospital

研究点 (1)

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