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

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03451318
• Other study ID #: 16CR2044B
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2018
• Last updated: April 17, 2018
• Start date: March 2, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: April 2018
• Source: Shanghai Stomotological Hospital
• Contact: Yuanyuan Li, Doctor
• Phone: 86-18817367760
• Email: liyuanyuan831[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Malocclusion
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Mometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray NASONEX

Procedure:
• tonsillar adenoidectomy
tonsillar adenoidectomy
• Maxillary expander plus Twin-Block
Twin-block appliance combined with maxillary expander

Locations

Country	Name	City	State
China	Shanghai Stomotological Hospital	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Stomotological Hospital	Shanghai Children's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Low arterial Oxygen Saturation (LSaO2) in PSG	LSaO2 increase after treatment	change from baseline at 7 months,1 year & 2 years post-treatment
Secondary	Airway volume change as shown on Cone Beam Computer Tomography (CBCT)	Airway volume increase after treatment	change from baseline at 7 months post-treatment
Secondary	ANB, Frankfort plane- Mandibular plane Angle (FMA) measurement using X-ray cephalometrics.	ANB & FMA (face development indicators) become normal after treatment	change from baseline at 7 months,1 year & 2 years post-treatment
Secondary	Assessment of subjective efficacy by using a "questionnaire on children's sleep symptoms"	Sleep quality improve after treatment.	change from baseline at 7 months,1 year & 2 years post-treatment