Clinical trial NCT03451318: Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
Official title: A Multicenter Study of Establishing the Multi-disciplinary Cooperative Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
Lead sponsor: Shanghai Stomotological Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Shanghai Children's Hospital
First posted: 2018-03-01
Enrollment: 400
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Obstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG）
timeFrame: change from baseline at 7 months,1 year & 2 years post-treatment
Secondary outcomes:
measure: Low arterial Oxygen Saturation （LSaO2） in PSG
timeFrame: change from baseline at 7 months,1 year & 2 years post-treatment
measure: Airway volume change as shown on Cone Beam Computer Tomography (CBCT)
timeFrame: change from baseline at 7 months post-treatment
measure: ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics.
timeFrame: change from baseline at 7 months,1 year & 2 years post-treatment
measure: Assessment of subjective efficacy by using a "questionnaire on children's sleep symptoms"
timeFrame: change from baseline at 7 months,1 year & 2 years post-treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Stomotological Hospital
Study officials:
affiliation: Department of Orthodonitcs,Shanghai Stomatological Hospital
name: Yuehua Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Wu J, Guo J, Yu L, Wang J, Li X, Xu S, Zhu M, Feng J, Liu Y. The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular retrognathia: study protocol for a multicenter randomized controlled trial. Trials. 2020 Jun 30;21(1):595. doi: 10.1186/s13063-020-04398-9.