Changes in Polysomnography and Rhinomanometry Parameters After Rapid Maxillary Expansion or Adenotonsilectomy in Children With Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- polysomnography measures
研究概览
简要总结
Adenotonsillectomy (AT) is considered the most effective and the standard treatment for Obstructive Sleep Apnea (OSA) in children. Since maxillary hypoplasia is a risk factor for OSA, Rapid Maxillary Expansion (RME) has been be considered as a complementary treatment in selected cases,improving the OSA. To compare changes in polysomnography (PSG) and in anterior active rhinomanometry (AAR) in children diagnosed with OSA, treated with RME or AT.
Methods: A sample of 51 children aged 5 to 10 years, diagnosed with OSA through PSG and referred for AT, was selected in a hospital based mouth-breathing specialized center. Children were divided in 2 groups: the AT group with 25 individuals, without maxillary hypoplasia, and the RME group composed of 26 children with maxillary constriction and posterior crossbite, with indication for RME before the AT surgery. Children underwent an initial evaluation at the time of selection (T0) and six months after the intervention: AT or RME (T1).
详细描述
PSG was performed to measure the apnea/hypopnea index (AHI), mean and minimum oxygen saturation (SpO2), desaturation index and desaturation time below 90%. AAR was used to measure nasal inspiratory flow (NIF), % NIF and nasal resistance. To compare the differences between the groups at T0, T1 and T1-T0, t-tests and Mann-Whitney tests were used. To compare the changes resulting from ERM and AT, paired t-tests and the Wilcoxon test were used, for a statistical significance level of 5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OSA confirmed by polysomnography
- •between 5 and 10 years of age
- •Indication for adenotonsillectomy (adenoids occupying more than 75% of the nasopharynx and/or tonsils classified as degree 3 or 4)
排除标准
- •Children with systemic diseases
- •craniofacial syndromes that interfered with functional and psychosocial development,
- •children who did not complete the expansion
- •parents did not sign the informed consent
结局指标
主要结局
polysomnography measures
时间窗: Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).
PSG was performed to measure the apnea/hypopnea index (AHI)
次要结局
- anterior active rhinomanometry measures(Children underwent at enrollment (T0) and six months after the intervention: AT or RME (T1).)
研究者
Mariana Maciel Tinano
Associate Professor, Outpatient clinic for the Mouth-breathers,
Federal University of Minas Gerais