Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy and safety of drug therapy, tonsillar adenoidectomy only, orthodontic treatment only and tonsillar adenoidectomy plus orthodontic treatment in children with obstructive sleep apnea hypopnea syndrome (OSAHS) and malocclusion. In this study, we hope to improve children's OSAH in function, three-dimensional shape and subjective and objective symptoms of sleep breathing through tonsillar adenoidectomy plus orthodontic treatment.

Official Title
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A Multicenter Study of Establishing the Multi-disciplinary Cooperative Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion

Conditions
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Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion

Intervention / Treatment
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* Drug: Mometasone Furoate Nasal Spray
* Procedure: tonsillar adenoidectomy
* Procedure: Maxillary expander plus Twin-Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as mild to moderate OSAHS Tonsil and/or adenoid hypertrophy Narrow dental arch and / or mandibular retrusion (ANB value≥ 4.5) The guardian / child can understand the study and sign the informed consent Exclusion Criteria: Patients with nasal obstruction disease The pathological obesity Patients with systemic disease Patient with central sleep apnea/hypopnea syndrome

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: drug therapy<br>Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months. | Drug: Mometasone Furoate Nasal Spray<br>* Mometasone Furoate Nasal Spray NASONEX<br>|
| Active Comparator: tonsillar adenoidectomy<br>tonsillar adenoidectomy | Procedure: tonsillar adenoidectomy<br>* tonsillar adenoidectomy<br>|
| Active Comparator: orthodontic treatment<br>Apply Twin-block appliance combined with maxillary expander | Procedure: Maxillary expander plus Twin-Block<br>* Twin-block appliance combined with maxillary expander<br>|
| Active Comparator: tonsillar adenoidectomy plus orthodontic treatment<br>Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy . | Procedure: tonsillar adenoidectomy<br>* tonsillar adenoidectomy<br>Procedure: Maxillary expander plus Twin-Block<br>* Twin-block appliance combined with maxillary expander<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG） | OAI/AHI (which are in negative correlation with oxygen saturation) decrease after treatment | change from baseline at 7 months,1 year & 2 years post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low arterial Oxygen Saturation （LSaO2） in PSG | LSaO2 increase after treatment | change from baseline at 7 months,1 year & 2 years post-treatment | 
| Airway volume change as shown on Cone Beam Computer Tomography (CBCT) | Airway volume increase after treatment | change from baseline at 7 months post-treatment | 
| ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics. | ANB & FMA (face development indicators) become normal after treatment | change from baseline at 7 months,1 year & 2 years post-treatment | 
| Assessment of subjective efficacy by using a questionnaire on children's sleep symptoms | Sleep quality improve after treatment. | change from baseline at 7 months,1 year & 2 years post-treatment |