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

Study Overview
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Brief Summary
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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™.

Detailed Description
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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.

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

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: Rapid palatal expansion
* Device: MGA™ system
* Device: Yoobreath™ system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with OSA<br> | Device: Rapid palatal expansion<br>* Fixation of rapid palatal expansion from day 0 to day 60<br>Device: MGA™ system<br>* 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)<br>Device: Yoobreath™ system<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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™) |  | 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™) |  | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep improvement | Measurement by polysomnography of desaturation index, micro arousal index and snoring index | Day -7, day 180 | 
| Assessment of quality of sleep | Assessment of quality of sleep by a questionnaire | Day 180 | 
| Assessment of quality of wakefulness | Assessment of quality of wakefulness by a questionnaire | Day 180 | 
| Measurement of lengthening of mandibular body and ramus | Assessment of mandible development by an orthodontist using cephalometric analysis | Day -7, day 180 | 
| Improvement of breathing | Improvement of breathing defined by polysomnography | Day -7, day 180 | 
| Assessment of dental occlusion | Assessment of dental occlusion (clinical and using casts): diagnosis of Angle class | Day -7, day 180 | 
| Assessement by the child and the parents of the treatment and the devices used | Assessement by the child and the parents of the treatment and the devices used by two questionnaires (one for parents and one for the child) | Day 180 | 
| Assessment of intensity of pain during rapid palatal expansion | Assessment of intensity of pain after fixing of rapid palatal expansion using a Visual Analogue Scale (VAS) | Day 60 | 
| Assessment of duration of pain during rapid palatal expansion | Number of painful days after fixing of rapid palatal expansion | Day 60 | 
| Assessment of intensity of dental pain the morning on waking after using the MGA™ system | Assessment of intensity of dental pain the morning on waking using a Visual Analogue Scale (VAS) | Day 60, day 90, day 120, day 150, day 180 | 
| Assessment of salivary disorders the morning on waking after using the MGA™ system | Assessment of salivary disorders the morning on waking by a questionnaire | Day 60, day 90, day 120, day 150, day 180 | 
| Assessment of duration of dental pain the morning on waking after using the MGA™ system | Number of painful days at the mandible the morning on waking | Day 60, day 90, day 120, day 150, day 180 | 
| Assessment of pain related to the semi-seated position | Assessment of pain related to the semi-seated position using a Visual Analogue Scale (VAS) | Day 15, day 60, day 90, day 120, day 150, day 180 | 
| Assessment of disorders in falling asleep and sleep quality (micro arousals) | Assessment of disorders in falling asleep and sleep quality (micro arousals) by a questionnaire | Day 15, day 60, day 90, day 120, day 150, day 180 | 
| Assessment of risk of falling using the Yoobreath system™ | Number of falls | Day 15, day 60, day 90, day 120, day 150, day 180 | 
| Assessment of the compliance | Reporting of side effects | Day 0, day 15, day 60, day 90, day 120, day 150, day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, Polysomnography, Rapid palatal expansion, Mandibular advancement, Sleep position