跳至主要内容
临床试验/NCT07086612
NCT07086612招募中不适用

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Transverse Orthodontic Deficiency in Children

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年11月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
1
主要终点
study whether children with a transverse orthodontic deficiency have a higher risk of developing Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) compared to those without this deficiency,

研究概览

简要总结

OSAHS (Obstructive Sleep Apnea Hypopnea Syndrome) in children is a frequent respiratory disorder, whose prevalence is estimated at between 1.2 and 5.7%, and which, if left untreated, can cause severe medical complications. This prevalence tends to be underestimated. Diagnosis is made following a clinical examination noting the presence of characteristic clinical and polysomnographic criteria. Multidisciplinary management has been widely described in the literature, and various therapeutic options have been indicated. Rapid maxillary expansion has proved highly effective in the treatment of this condition. This syndrome is a real public health problem and must be diagnosed as early as possible. Through our research, we would like to study whether there is a causal link between an orthodontic problem of the transverse direction and the presence of SAHOS in children. In other words, we would like to assess whether children who clinically present an orthodontic deficiency of their transverse dimension are more likely to develop SAHOS than children without this deficit. If this proves to be true, then a new clinical sign could enable certain healthcare professionals to detect this syndrome early, and be able to refer patients to physicians as soon as possible.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient aged between 6 and 16 years
  • Patients with a transverse orthodontic deficiency (group "CAS")
  • Patients with another type of orthodontic deficiency (group "CONTROL") such as tooth rotation, crowding, mild Angle Class II or Class III dental occlusion
  • Patient who has given free, informed oral consent
  • Patient whose legal representatives have given their free written consent
  • Patient affiliated with a health insurance scheme

排除标准

  • Patients refusing to participate in the study
  • Patients whose legal representatives refuse to participate in the study

结局指标

主要结局

study whether children with a transverse orthodontic deficiency have a higher risk of developing Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) compared to those without this deficiency,

时间窗: 1 months after enrollement

compare the proportion of children with an Apnea-Hypopnea Index (AHI) \>1, , based on the presence or absence of a transverse deficiency." AHI is evaluated with the polysomnography exam

次要结局

  • study whether all children with a transverse orthodontic deficiency systematically have Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)(one month after enrollement)
  • Investigate a link between the severity of this transverse deficiency and the severity of OSAHS.(1month after enrollement)
  • impact of hteSeverity of transferse deficiency on the snoring events frequency.(1months after enrollement)
  • diagnostic value of the sleep disorder screening scale for children aged 4 to 16 years(1month after enrollement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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