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临床试验/NCT02233166
NCT02233166Unknown不适用

Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy

Lovisenberg Diakonale Hospital1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
115
试验地点
1
主要终点
Prevalence of OSA

研究概览

简要总结

In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. Studies in recent years have shown that the procedure does not always have the expected effect. Children with OSA are at greater risk for complications from the procedure.

There is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography (PSG).

The main purpose of this study is to describe the prevalence of OSA among children referred for adenotonsillectomy.

The investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life.

The project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with OSA.

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
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 2-5 year
  • referred for adenoidectomy and/or tonsillectomy

排除标准

  • craniofacial anomalies
  • neurological diseases
  • neuropsychiatric diseases

结局指标

主要结局

Prevalence of OSA

时间窗: Up to 2 years

Apne hypopne index (AHI)/ respiratory disturbance index (RDI)

次要结局

  • Post operative PSG results(Up to 2 years)

研究者

发起方
Lovisenberg Diakonale Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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