Status:
UNKNOWN
Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
Lead Sponsor:
Shanghai Stomotological Hospital
Collaborating Sponsors:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Children's Hospital
Conditions:
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
Eligibility:
All Genders
4-10 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- Patients with nasal obstruction disease
- The pathological obesity
- Patients with systemic disease
- Patient with central sleep apnea/hypopnea syndrome
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2020
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03451318
Start Date
March 2 2018
End Date
May 30 2020
Last Update
April 19 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Stomotological Hospital
Shanghai, China, 200001