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NCT Number: NCT07086612

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

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.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'orthopédie dento-cranio-maxillo faciale

Rouen, 7600, France

Location status: Recruiting

Location contact

Perrine KRUK, MD

CONTACT

[email protected]

+3344127963

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

over nigtht ventilatory polysomnograph test

Diagnostic Test

Every patient will have an overnight polysomnography test.

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,

    Time frame: 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

Secondary outcomes

  1. study whether all children with a transverse orthodontic deficiency systematically have Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

    Time frame: one month after enrollement

    distribution of Apnea-Hypopnea Index (AHI) values among these children

  2. Investigate a link between the severity of this transverse deficiency and the severity of OSAHS.

    Time frame: 1month after enrollement

    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.

  3. impact of hteSeverity of transferse deficiency on the snoring events frequency.

    Time frame: 1months after enrollement

    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.

  4. diagnostic value of the sleep disorder screening scale for children aged 4 to 16 years

    Time frame: 1month after enrollement

    comparison of the sleep disorder screening scale results with the results of the polysomnography exam.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: ASCOT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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