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

Not Applicable

• Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
• Interventions: Drug: Mometasone Furoate Nasal Spray; Procedure: tonsillar adenoidectomy; Procedure: Maxillary expander plus Twin-Block

• Registration Number: NCT03451318
• Lead Sponsor: Shanghai Stomotological Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-03-01
• Study Start: 2018-03-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19
• Primary Completion: 2019-05-30
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Diagnosed as mild to moderate OSAHS
2. Tonsil and/or adenoid hypertrophy
3. Narrow dental arch and / or mandibular retrusion (ANB value≥ 4.5)
4. The guardian / child can understand the study and sign the informed consent

Exclusion Criteria

1. Patients with nasal obstruction disease
2. The pathological obesity
3. Patients with systemic disease
4. Patient with central sleep apnea/hypopnea syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug therapy	Mometasone Furoate Nasal Spray	Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months.
tonsillar adenoidectomy	tonsillar adenoidectomy	tonsillar adenoidectomy
orthodontic treatment	Maxillary expander plus Twin-Block	Apply Twin-block appliance combined with maxillary expander
tonsillar adenoidectomy plus orthodontic treatment	tonsillar adenoidectomy	Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy .
tonsillar adenoidectomy plus orthodontic treatment	Maxillary expander plus Twin-Block	Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy .

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Stomotological Hospital; 🇨🇳 Shanghai, China