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Recruiting NCT07086612

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

No phase Interventional Obstructive Sleep Apnea Transverse Maxillary Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: over nigtht ventilatory polysomnograph test.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Transverse Maxillary Deficiency. Basic parameters: 6 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test over nigtht ventilatory polysomnograph test
    Every patient will have an overnight polysomnography test.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Service d'orthopédie dento-cranio-maxillo faciale — Rouen

Identifiers

NCT: NCT07086612 · 761-ASCOT · 2025-A00478-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗