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临床试验/NCT02463201
NCT02463201已完成不适用

Obstructive Sleep Apnea in Obese Children and Teenagers - Occurrence and Importance of Intervention

Zealand University Hospital2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
236
试验地点
2
主要终点
Change in obstructive sleep apnea (OSA)

研究概览

简要总结

The prevalence of childhood obesity has increased at an alarming rate over the last decades, both globally and in Denmark. There are a number of serious sequelae related to obesity, such as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to be a risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be associated with cardiovascular complications, neurocognitive problems and reduced quality of life. The correlation between obesity and OSA is still poorly understood. Early detection and intervention is of great importance as the health consequences related to OSA as well as obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with OSA. However, only around 25% of obese children benefit from this treatment compared to around 75% of normal-weight children suggesting that there might be other structural factors predisposing to OSA in obese children.

In this study the investigators aim to clarify the impact of obesity in the development of OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose is to assess the effect of weight loss on 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
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 7-18 years
  • BMI > 90th percentile for age and gender

排除标准

  • Neuromuscular disorders
  • Craniofacial syndromes / malformations
  • Laryngeal and tracheal malformations

结局指标

主要结局

Change in obstructive sleep apnea (OSA)

时间窗: One year

OSA will be diagnosed by cardiorespiratory measurement. The examination will be repeated after weight loss.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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