Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development (SAOS)

Rennes University Hospital

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: Yoobreath™ system; Device: MGA™ system; Device: Rapid palatal expansion

Study type: Interventional

Funder types: Other

Identifiers

NCT03267927

35RC16_9851_SAOS

Details and patient eligibility

About

Assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™ constitute the Yookid system™.

Full description

Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated. Furthermore, detecting OSA remains difficult due to its particular physiopathology. The decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is to show that reducing sleep apnea in children remains possible when inducing rapid palatal expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates a mandibular advancement appliance and repositioning of the patient during sleep.

Enrollment: 4 patients

Sex: All

Ages: 5 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 5 to 7 year-old children
• Children with American Society of Anesthesiologists score (ASA) of 1 and 2
• Children with signs of OSA during examination and clinical exam
• Children with apnea-hypopnea index (AHI) from 1 to 5 (one to five sleep apnea / hour during PSG)
• Children with a class II division 1 angle malocclusion (at the canines level rotation center) and skeletal class II according to Delaire analysis

Exclusion criteria

• OSA associated to syndromic disorder and/or syndrome
• Body/Mass Index (BMI) > 97ème percentile according to development curves (obese children)
• Central sleep apnea
• Respiratory allergy
• Previous ear, nose and throat (ENT) surgery
• Hypertrophic tonsils needing surgery
• Adenoid hypertrophy needing surgery
• Patients with ankyloglossia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Patient with OSA

Experimental group

Treatment:

Device: Rapid palatal expansion

Device: MGA™ system

Device: Yoobreath™ system