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

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ClinicalTrials.gov Identifier: NCT03451318
Recruitment Status : Unknown
Verified April 2018 by Shanghai Stomotological Hospital.
Recruitment status was:  Recruiting
First Posted : March 1, 2018
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Children's Hospital
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion Drug: Mometasone Furoate Nasal Spray Procedure: tonsillar adenoidectomy Procedure: Maxillary expander plus Twin-Block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Arm Intervention/treatment
Active Comparator: drug therapy
Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months.
Drug: Mometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray NASONEX

Active Comparator: tonsillar adenoidectomy
tonsillar adenoidectomy
Procedure: tonsillar adenoidectomy
tonsillar adenoidectomy

Active Comparator: orthodontic treatment
Apply Twin-block appliance combined with maxillary expander
Procedure: Maxillary expander plus Twin-Block
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 .
Procedure: tonsillar adenoidectomy
tonsillar adenoidectomy

Procedure: Maxillary expander plus Twin-Block
Twin-block appliance combined with maxillary expander




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451318


Contacts
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Contact: Yuanyuan Li, Doctor 86-18817367760 liyuanyuan831@sina.com
Contact: Huanbqing Shan 86-13564158276 362911628@qq.com

Locations
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China
Shanghai Stomotological Hospital Recruiting
Shanghai, China, 200001
Contact: Yuanyuan Li, Doctor    18817367760    liyuanyuan831@sina.com   
Principal Investigator: Yuehua Liu, Professor         
Sponsors and Collaborators
Shanghai Stomotological Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Children's Hospital
Investigators
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Principal Investigator: Yuehua Liu, Professor Department of Orthodonitcs,Shanghai Stomatological Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Stomotological Hospital
ClinicalTrials.gov Identifier: NCT03451318    
Other Study ID Numbers: 16CR2044B
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malocclusion
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Tooth Diseases
Stomatognathic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents