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临床试验/NCT03034447
NCT03034447已完成不适用

Obstructive Sleep Apnea in Asthmatic Children: Does the Sex Matter?

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016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
80
试验地点
2
主要终点
Sleep Apnea Syndrome

研究概览

简要总结

Asthma and sleep apnea are both respiratory diseases and one can worsen the other. Those who suffer from asthma have a higher risk of sleep apnea and sleep apnea can make the asthma more difficult to control.

As girls usually have a more severe asthma than boys, the investigators believe that girls have a higher risk of sleep apnea.

To test if asthmatic girls have more sleep apnea than boys, the investigators are going to ask them questions regarding asthma and sleep symptoms (such as snore) and the investigators are going test the lung function and how many times they stop breathing during the sleep. The sleep test is going to be performed in children's home.

In children, having sleep apnea can make the asthmatic stay in the hospital 30% more when they have an asthma attack. We also are going to look if sleep apnea increases the number of hospitalizations and asthma attacks in the past 12 months.

详细描述

Obstructive sleep apnea (OSA) and asthma are both inflammatory airway diseases. A systematic review regarding sleep-disordered breathing (SDB) in asthmatic children analyzed 17 studies but only two of them had objective OSA measurement. In total, 45,115 children were included, 53% boys, mean age 8.6 ± 2.5 years. SDB was present in 23.8% of asthmatic children and in 16.7% of non-asthmatic (p < 0.001, OR 1.9, 95%CI 1.7-2.2).

An American study found that OSA in asthmatic children increases hospital length of stay (OR 2.3; 95% CI = 1.8 - 2.9). Brazilian database of the year 2015 showed that, among children 5-19 years, asthma was the 5th cause of hospitalization: a total of 2.4% of the hospitalization in this age group, after birth and its complication (31%), limb fractures (5.7%), pneumonia (3.8%), and appendicitis (3.2%).

The relationship among asthma severity (mild, moderate, and severe) and OSA has been described previously, but not in every study. Poor asthma control has also been linked to a higher OSA risk in adults and children.

OSA and asthma share many risk factors: rhinitis, increased collapsibility of the upper airway, local and systemic inflammation, gastroesophageal reflux, and obesity.

A higher risk of SDB in asthmatic girls has recently been described (OR 2.55 for girls and 0.70 for boys). Among non-asthmatic children OSA is usually equal among boys and girls until adolescence. A possible explanation is asthma severity in children: younger boys are more severe but after puberty, girls are.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Persistent asthma

排除标准

  • Craniofacial malformation
  • Thoracic malformation
  • Genetic syndromes
  • Bronchopulmonary dysplasia
  • Bronchiolitis obliterans
  • Neuromuscular diseases
  • Sickle cell anemia
  • Cystic fibrosis

研究组 & 干预措施

Asthma

Other

Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study

干预措施: Questionnaire (Other)

Asthma

Other

Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study

干预措施: Lung Function Test (Other)

Asthma

Other

Children and teenagers with persistent asthma will perform questionnaires, lung function test, and home sleep study

干预措施: Home Sleep Study (Other)

结局指标

主要结局

Sleep Apnea Syndrome

时间窗: 1 night

Apneas and hypopneas during sleep

次要结局

  • ER visits(1 year)
  • Lung function(1 day)
  • Asthma Control(4 weeks)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gustavo Antonio Moreira

Medical Doctor

Federal University of São Paulo

研究点 (2)

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