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

Primary Purpose

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mometasone Furoate Nasal Spray
tonsillar adenoidectomy
Maxillary expander plus Twin-Block
Sponsored by
Shanghai Stomotological Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Stomotological HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

drug therapy

tonsillar adenoidectomy

orthodontic treatment

tonsillar adenoidectomy plus orthodontic treatment

Arm Description

Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months.

tonsillar adenoidectomy

Apply Twin-block appliance combined with maxillary expander

Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy .

Outcomes

Primary Outcome Measures

Obstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG）
OAI/AHI (which are in negative correlation with oxygen saturation) decrease after treatment

Secondary Outcome Measures

Low arterial Oxygen Saturation （LSaO2） in PSG
LSaO2 increase after treatment
Airway volume change as shown on Cone Beam Computer Tomography (CBCT)
Airway volume increase after treatment
ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics.
ANB & FMA (face development indicators) become normal after treatment
Assessment of subjective efficacy by using a "questionnaire on children's sleep symptoms"
Sleep quality improve after treatment.

Full Information

First Posted
February 7, 2018
Last Updated
April 17, 2018
Sponsor
Shanghai Stomotological Hospital
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03451318
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Anticipated)
Study Completion Date
May 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Stomotological Hospital
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drug therapy
Arm Type
Active Comparator
Arm Description
Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months.
Arm Title
tonsillar adenoidectomy
Arm Type
Active Comparator
Arm Description
tonsillar adenoidectomy
Arm Title
orthodontic treatment
Arm Type
Active Comparator
Arm Description
Apply Twin-block appliance combined with maxillary expander
Arm Title
tonsillar adenoidectomy plus orthodontic treatment
Arm Type
Active Comparator
Arm Description
Apply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy .
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate Nasal Spray
Intervention Description
Mometasone Furoate Nasal Spray NASONEX
Intervention Type
Procedure
Intervention Name(s)
tonsillar adenoidectomy
Intervention Description
tonsillar adenoidectomy
Intervention Type
Procedure
Intervention Name(s)
Maxillary expander plus Twin-Block
Intervention Description
Twin-block appliance combined with maxillary expander
Primary Outcome Measure Information:
Title
Obstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG）
Description
OAI/AHI (which are in negative correlation with oxygen saturation) decrease after treatment
Time Frame
change from baseline at 7 months,1 year & 2 years post-treatment
Secondary Outcome Measure Information:
Title
Low arterial Oxygen Saturation （LSaO2） in PSG
Description
LSaO2 increase after treatment
Time Frame
change from baseline at 7 months,1 year & 2 years post-treatment
Title
Airway volume change as shown on Cone Beam Computer Tomography (CBCT)
Description
Airway volume increase after treatment
Time Frame
change from baseline at 7 months post-treatment
Title
ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics.
Description
ANB & FMA (face development indicators) become normal after treatment
Time Frame
change from baseline at 7 months,1 year & 2 years post-treatment
Title
Assessment of subjective efficacy by using a "questionnaire on children's sleep symptoms"
Description
Sleep quality improve after treatment.
Time Frame
change from baseline at 7 months,1 year & 2 years post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Li, Doctor
Phone
86-18817367760
Email
liyuanyuan831@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huanbqing Shan
Phone
86-13564158276
Email
362911628@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuehua Liu, Professor
Organizational Affiliation
Department of Orthodonitcs,Shanghai Stomatological Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Stomotological Hospital
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Li, Doctor
Phone
18817367760
Email
liyuanyuan831@sina.com
First Name & Middle Initial & Last Name & Degree
Yuehua Liu, Professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
32605655
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.
Results Reference
derived

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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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