- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03451318
Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
A Multicenter Study of Establishing the Multi-disciplinary Cooperative Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuanyuan Li, Doctor
- Phone Number: 86-18817367760
- Email: liyuanyuan831@sina.com
Study Contact Backup
- Name: Huanbqing Shan
- Phone Number: 86-13564158276
- Email: 362911628@qq.com
Study Locations
-
-
-
Shanghai, China, 200001
- Recruiting
- Shanghai Stomotological Hospital
-
Contact:
- Yuanyuan Li, Doctor
- Phone Number: 18817367760
- Email: liyuanyuan831@sina.com
-
Principal Investigator:
- Yuehua Liu, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: drug therapy
Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months.
|
Mometasone Furoate Nasal Spray NASONEX
|
ACTIVE_COMPARATOR: tonsillar adenoidectomy
|
tonsillar adenoidectomy
|
ACTIVE_COMPARATOR: orthodontic treatment
Apply Twin-block appliance combined with maxillary expander
|
Twin-block appliance combined with maxillary expander
|
ACTIVE_COMPARATOR: tonsillar adenoidectomy plus orthodontic treatment
Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy .
|
tonsillar adenoidectomy
Twin-block appliance combined with maxillary expander
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obstructive Apnea Index(OAI)/ Apnea Hypopnea Index (AHI) in PolySomnoGraphy (PSG)
Time Frame: 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
|
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
Time Frame: change from baseline at 7 months,1 year & 2 years post-treatment
|
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)
Time Frame: change from baseline at 7 months post-treatment
|
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.
Time Frame: change from baseline at 7 months,1 year & 2 years post-treatment
|
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"
Time Frame: change from baseline at 7 months,1 year & 2 years post-treatment
|
Sleep quality improve after treatment.
|
change from baseline at 7 months,1 year & 2 years post-treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yuehua Liu, Professor, Department of Orthodonitcs,Shanghai Stomatological Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Stomatognathic Diseases
- Tooth Diseases
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Malocclusion
- Anti-Inflammatory Agents
- Dermatologic Agents
- Anti-Allergic Agents
- Mometasone Furoate
Other Study ID Numbers
- 16CR2044B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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