Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and MalocclusionNCT03451318
Multi-disciplinary Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion
A study testing Mometasone Furoate Nasal Spray, tonsillar adenoidectomy and Maxillary expander plus Twin-Block in people with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion, run by Shanghai Stomotological Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
- What is being tested?
- Mometasone Furoate Nasal Spray, tonsillar adenoidectomy and Maxillary expander plus Twin-Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients with nasal obstruction disease
- The pathological obesity
- Patients with systemic disease
- Patient with central sleep apnea/hypopnea syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Stomotological Hospital
Shanghai, 200001
Yuanyuan Li, Doctor, 18817367760, liyuanyuan831@sina.com
Yuehua Liu, Professor
About this study
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
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.
- Being tested
- Mometasone Furoate Nasal Spray, tonsillar adenoidectomy, Maxillary expander plus Twin-Block
- Medical subject headings
- Sleep Apnea, Obstructive, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate Nasal SprayDrug
Mometasone Furoate Nasal Spray NASONEX
tonsillar adenoidectomyProcedure or surgery
tonsillar adenoidectomy
Maxillary expander plus Twin-BlockProcedure or surgery
Twin-block appliance combined with maxillary expander
| Study group | Role | What they receive |
|---|---|---|
| drug therapy | Active comparator | Nasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months. Receives: Drug: Mometasone Furoate Nasal Spray |
| tonsillar adenoidectomy | Active comparator | tonsillar adenoidectomy Receives: Procedure: tonsillar adenoidectomy |
| orthodontic treatment | Active comparator | Apply Twin-block appliance combined with maxillary expander Receives: 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 . Receives: Procedure: tonsillar adenoidectomy; Procedure: Maxillary expander plus Twin-Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive Apnea Index（OAI）/ Apnea Hypopnea Index （AHI） in PolySomnoGraphy （PSG）
OAI/AHI (which are in negative correlation with oxygen saturation) decrease after treatment
Measured: change from baseline at 7 months,1 year & 2 years post-treatment
Secondary outcomes (4)
Low arterial Oxygen Saturation （LSaO2） in PSG
LSaO2 increase after treatment
Measured: change from baseline at 7 months,1 year & 2 years post-treatment
Airway volume change as shown on Cone Beam Computer Tomography (CBCT)
Airway volume increase after treatment
Measured: change from baseline at 7 months post-treatment
ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics.
ANB \& FMA (face development indicators) become normal after treatment
Measured: 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"
Sleep quality improve after treatment.
Measured: change from baseline at 7 months,1 year & 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start2 Mar 2018
- Primary completion30 May 2019 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Stomotological Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Yuehua Liu, Professor, Principal investigator, Department of Orthodonitcs,Shanghai Stomatological Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451318
- Sponsor's protocol ID
- 16CR2044B
- Status last verified
- Apr 2018
- First submitted
- 7 Feb 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03451318
- Acronym / sponsor ID
- 16CR2044B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Stomotological HospitalUniversity, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Children's Hospital
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| drug therapy | Active comparator | Drug: Mometasone Furoate Nasal SprayNasonex(mometasone furoate),1 spray,QD (Quaque Die in Latin),for 3 months. |
| tonsillar adenoidectomy | Active comparator | Procedure: tonsillar adenoidectomytonsillar adenoidectomy |
| orthodontic treatment | Active comparator | Procedure: Maxillary expander plus Twin-BlockApply Twin-block appliance combined with maxillary expander |
| tonsillar adenoidectomy plus orthodontic treatment | Active comparator | Procedure: tonsillar adenoidectomy, Procedure: Maxillary expander plus Twin-BlockApply Twin-block appliance combined with maxillary expander one month after tonsillar adenoidectomy . |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients with nasal obstruction disease
- The pathological obesity
- Patients with systemic disease
- Patient with central sleep apnea/hypopnea syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone Furoate Nasal SprayMometasone Furoate Nasal Spray NASONEX | Drug | drug therapy |
| tonsillar adenoidectomytonsillar adenoidectomy | Procedure or surgery | tonsillar adenoidectomy, tonsillar adenoidectomy plus orthodontic treatment |
| Maxillary expander plus Twin-BlockTwin-block appliance combined with maxillary expander | Procedure or surgery | orthodontic treatment, tonsillar adenoidectomy plus orthodontic treatment |
Primary outcome
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
4 secondary outcomes
Low arterial Oxygen Saturation （LSaO2） in PSG
Time frame: 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Derived from this study: PubMed 32605655Li 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.
Related trials for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
Recruiting
IOA Preventing Occlusal Changes With MAD Use
Sleep Related Breathing Disorder, Snoring
Enrolling by invitation
Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction
Apnea, Obstructive Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuehua Liu, Professor principal investigator
Department of Orthodonitcs,Shanghai Stomatological Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mometasone Furoate Nasal Spray, tonsillar adenoidectomy and Maxillary expander plus Twin-Block in people with Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion, run by Shanghai Stomotological Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Li, Doctor (86-18817367760, liyuanyuan831@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03451318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.