Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
Conditions
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.
Interventions
DRUGMometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray NASONEX
PROCEDUREtonsillar adenoidectomy
tonsillar adenoidectomy
PROCEDUREMaxillary expander plus Twin-Block
Twin-block appliance combined with maxillary expander
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Children's Hospital
Shanghai Stomotological Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Low arterial Oxygen Saturation （LSaO2） in PSG | change from baseline at 7 months,1 year & 2 years post-treatment | LSaO2 increase after treatment |
| 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. |
Countries
China
Contacts
Primary ContactYuanyuan Li, Doctor
Backup ContactHuanbqing Shan
Outcome results
None listed