NCT03451318

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 2, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

February 7, 2018

Last Update Submit

April 17, 2018

Conditions

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion

Outcome Measures

Primary Outcomes (1)

  • Obstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG）

    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 Outcomes (4)

  • Low arterial Oxygen Saturation （LSaO2） in PSG

    change from baseline at 7 months,1 year & 2 years post-treatment

  • Airway volume change as shown on Cone Beam Computer Tomography (CBCT)

    change from baseline at 7 months post-treatment

  • ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics.

    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"

    change from baseline at 7 months,1 year & 2 years post-treatment

Study Arms (4)

drug therapy

ACTIVE COMPARATOR

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

Drug: Mometasone Furoate Nasal Spray

tonsillar adenoidectomy

ACTIVE COMPARATOR

tonsillar adenoidectomy

Procedure: tonsillar adenoidectomy

orthodontic treatment

ACTIVE COMPARATOR

Apply Twin-block appliance combined with maxillary expander

Procedure: Maxillary expander plus Twin-Block

tonsillar adenoidectomy plus orthodontic treatment

ACTIVE COMPARATOR

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

Procedure: tonsillar adenoidectomyProcedure: Maxillary expander plus Twin-Block

Interventions

Mometasone Furoate Nasal SprayDRUG

Mometasone Furoate Nasal Spray NASONEX

drug therapy
tonsillar adenoidectomyPROCEDURE

tonsillar adenoidectomy

tonsillar adenoidectomytonsillar adenoidectomy plus orthodontic treatment
Maxillary expander plus Twin-BlockPROCEDURE

Twin-block appliance combined with maxillary expander

orthodontic treatmenttonsillar adenoidectomy plus orthodontic treatment

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with nasal obstruction disease
  • The pathological obesity
  • Patients with systemic disease
  • Patient with central sleep apnea/hypopnea syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Stomotological Hospital

Shanghai, 200001, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32605655DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMalocclusion

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Yuehua Liu, Professor

    Department of Orthodonitcs,Shanghai Stomatological Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanyuan Li, Doctor

CONTACT

86-18817367760liyuanyuan831@sina.com

Huanbqing Shan

CONTACT

86-13564158276362911628@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 1, 2018

Study Start

March 2, 2018

Primary Completion

May 30, 2019

Study Completion

May 30, 2020

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

CN(1)