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Status unknownNCT03451318Updated Apr 19, 2018

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

An interventional study of Mometasone Furoate Nasal Spray and tonsillar adenoidectomy in Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion, sponsored by Shanghai Stomotological Hospital. Status unknown at 1 site in China. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2018-04-19.

Sponsored by Shanghai Stomotological Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
03

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    drug therapy

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

    Drug: Mometasone Furoate Nasal Spray

  • Active comparator
    tonsillar adenoidectomy

    tonsillar adenoidectomy

    Procedure: tonsillar adenoidectomy

  • Active comparator
    orthodontic treatment

    Apply Twin-block appliance combined with maxillary expander

    Procedure: Maxillary expander plus Twin-Block

  • Active comparator
    tonsillar adenoidectomy plus orthodontic treatment

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

    Procedure: tonsillar adenoidectomy · Procedure: Maxillary expander plus Twin-Block

Interventions

  • DrugMometasone Furoate Nasal Spray

    Mometasone Furoate Nasal Spray NASONEX

  • Proceduretonsillar adenoidectomy

    tonsillar adenoidectomy

  • ProcedureMaxillary expander plus Twin-Block

    Twin-block appliance combined with maxillary expander

05

What researchers measure

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

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

Secondary outcomes

  1. Low arterial Oxygen Saturation （LSaO2） in PSG

    LSaO2 increase after treatment

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

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

    Airway volume increase after treatment

    Time frame: change from baseline at 7 months post-treatment

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

    ANB \& FMA (face development indicators) become normal after treatment

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

  4. Assessment of subjective efficacy by using a "questionnaire on children's sleep symptoms"

    Sleep quality improve after treatment.

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

06

Study locations

1 of 1 sites recruiting
  • Shanghai Stomotological Hospital
    Shanghai, 200001, China
    • Yuanyuan Li, Doctor · Contact · liyuanyuan831@sina.com · 18817367760
    • Yuehua Liu, Professor · Principal investigator
    Recruiting
07

References and documents

Publications

  • 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. PubMed 32605655 ↗
08

Registry details

Key details

Study ID
NCT03451318
Lead sponsor
Shanghai Stomotological Hospital
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Children's Hospital
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
Mar 2, 2018
Primary completion
May 30, 2019 (estimated)
Completion
May 30, 2020 (estimated)
Last update
Apr 19, 2018

Study contacts

Yuanyuan Li, Doctor
Contact
liyuanyuan831@sina.com
86-18817367760
Huanbqing Shan
Contact
362911628@qq.com
86-13564158276
Yuehua Liu, Professor
principal investigator · Department of Orthodonitcs,Shanghai Stomatological Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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