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

NCT ID: NCT07086612

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

transverse deficiency maxilla

patient with transverse deficiency maxilla

Group Type: EXPERIMENTAL

over nigtht ventilatory polysomnograph test

Intervention Type: DIAGNOSTIC_TEST

Every patient will have an overnight polysomnography test.

other type of maxilla deficiency

patient with other type maxilla deficiency

Group Type: OTHER

over nigtht ventilatory polysomnograph test

Intervention Type: DIAGNOSTIC_TEST

Every patient will have an overnight polysomnography test.

Interventions

over nigtht ventilatory polysomnograph test

Every patient will have an overnight polysomnography test.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'orthopédie dento-cranio-maxillo faciale

Rouen, , France

Countries

France

Facility Contacts

Perrine KRUK, MD

Role: primary

kruk.perrine@live.fr

+3344127963

Other Identifiers

2025-A00478-41

Identifier Type: OTHER

Identifier Source: secondary_id

761-ASCOT

Identifier Type: -

Identifier Source: org_study_id