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

NCT07086612 | Recruiting

• 2 other identifiers: 761-ASCOT2025-A00478-41
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Transverse Maxillary Deficiency

Outcome Measures

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

  1 months after enrollement

Secondary Outcomes (4)

• 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

Study Arms (2)

transverse deficiency maxilla

EXPERIMENTAL

patient with transverse deficiency maxilla

Diagnostic Test: over nigtht ventilatory polysomnograph test

other type of maxilla deficiency

OTHER

patient with other type maxilla deficiency

Diagnostic Test: over nigtht ventilatory polysomnograph test

Interventions

over nigtht ventilatory polysomnograph test DIAGNOSTIC_TEST

Every patient will have an overnight polysomnography test.

other type of maxilla deficiency; transverse deficiency maxilla

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Service d'orthopédie dento-cranio-maxillo faciale

Rouen, 7600, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)