Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Transverse Orthodontic Deficiency in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorFondation Hôpital Saint-Joseph
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients refusing to participate in the study
Patients whose legal representatives refuse to participate in the study
Trial design
Design model
Single group
Treatments tested in this trial
over nigtht ventilatory polysomnograph test
Diagnostic testEvery patient will have an overnight polysomnography test.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: transverse deficiency maxillaExperimental treatment 1 intervention
Group B: other type of maxilla deficiencyOther 1 intervention
Trial outcomes
Primary outcomes
1
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,
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
Time frame
1 months after enrollementSecondary outcomes
1
study whether all children with a transverse orthodontic deficiency systematically have Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
distribution of Apnea-Hypopnea Index (AHI) values among these children
Time frame
one month after enrollement2
Investigate a link between the severity of this transverse deficiency and the severity of OSAHS.
Distribution of AHI values among children based on the extent of the transverse deficiency. Three groups will be formed for the transverse deficiency : one for pure endognathies, one for endoalveolies, and one for crossbite occlusions.". AHI is evaluated with the polysomnography exam.
Time frame
1month after enrollement3
impact of hteSeverity of transferse deficiency on the snoring events frequency.
Average number of snoring events per hour based on the severity of the transverse deficiency. Three groups for the transverse defficiency will be formed: one for pure endognathies, one for endoalveolies, and one for crossbite occlusions. Number of snoring event will be mesured by the polysomnography exam.
Time frame
1months after enrollement4
diagnostic value of the sleep disorder screening scale for children aged 4 to 16 years
comparison of the sleep disorder screening scale results with the results of the polysomnography exam.
Time frame
1month after enrollementSponsors and contacts
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Source ClinicalTrials.gov