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

April 17, 2018 updated by: Shanghai Stomotological Hospital

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

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Shanghai, China, 200001
        • Recruiting
        • Shanghai Stomotological Hospital
        • Contact:
        • Principal Investigator:
          • Yuehua Liu, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yuehua Liu, Professor, Department of Orthodonitcs,Shanghai Stomatological Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 2, 2018

Primary Completion (ANTICIPATED)

May 30, 2019

Study Completion (ANTICIPATED)

May 30, 2020

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (ACTUAL)

March 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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