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

Rennes University Hospital4 enrolled

Overview

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™.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

Rapid palatal expansionDEVICE

Fixation of rapid palatal expansion from day 0 to day 60

MGA™ systemDEVICE

Use of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained)

Yoobreath™ systemDEVICE

Use of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained)

Eligibility

Sex: ALLMin age: 5 YearsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Rennes

Rennes, France

Outcomes

Primary Outcomes

Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with advancement using a mandibular advancement appliance (MGA™)

Time frame: Day 180

Assessment in 5 to 7 year-old children the efficacy on OSA (removal or decrease of apnea/hypopnea) of Rapid Palatal Expansion combined with a device allowing a semi-seated sleeping position (YooBreath™)

Time frame: Day 180

Secondary Outcomes

Sleep improvement

Measurement by polysomnography of desaturation index, micro arousal index and snoring index

Time frame: Day -7, day 180

Assessment of quality of sleep

Assessment of quality of sleep by a questionnaire

Time frame: Day 180

Assessment of quality of wakefulness

Assessment of quality of wakefulness by a questionnaire

Time frame: Day 180

Measurement of lengthening of mandibular body and ramus

Assessment of mandible development by an orthodontist using cephalometric analysis

Time frame: Day -7, day 180

Improvement of breathing

Improvement of breathing defined by polysomnography

Time frame: Day -7, day 180

Assessment of dental occlusion

Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class

Time frame: Day -7, day 180

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.