Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.

Study Overview
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Brief Summary
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In this project,the investigators aim to establish a Collaborative Care Model of TCM and Western Medicine to improve the quality of life and symptoms of AR with OSA children and educate care-givers diet and massage information to improve self-care ability and alleviate anxiety for parents. In addition, the investigators will use portable oxymeter to detect the change of SpO2 and respiratory arousal index daily at home and evaluate sensitivity and specificity of portable oxymeter device applied in OSA. The investigators want to give holistic health care for participants and care-givers by this project. In addition, the investigators will build a training environment to provide medical education and training opportunity to teach medical students and clinician the knowledge of pediatric allergic rhinitis and obstructive sleep apnea by caring patients and learning from clinical cases.

Detailed Description
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Obstructive sleep apnea (OSA) affects 1-6% among children and has negative influence on day-time school performance and quality of sleep. It also cause failure to thrive，cardiovascular disease，and metabolic disease, which need early intervention. About 6% allergic rhinitis (AR) children would combine with OSA and refractory to treatment and need long-term intra-nasal corticosteroid or surgery if have moderate-severe OSA with adenoid-tonsillar hypertrophy. Some parents considering the side effect of steroid and risk of surgery will search Traditional Chinese Medicine (TCM) for help. TCM is one kind of preventive medicine by educating people how to keep health by diet and massage. The breathing technique and Teeth-Buckling and Salivary-Swallowing motion noted in Inner Canon of the Yellow Emperor, one of the most important ancient Chinese medical text are compatible with myofunctional therapy for OSA. There are several studies revealed improve immune response in allergic rhinitis by TCM and severity of OSA by acupuncture. In this project, the investigators aim to establish a Collaborative Care Model of TCM and Western Medicine to improve the quality of life and symptoms of AR with OSA children and educate care-givers diet and massage information to improve self-care ability and alleviate anxiety for parents. In addition, the investigators will use portable oxymeter to detect the change of SpO2 and respiratory arousal index daily at home and evaluate sensitivity and specificity of portable oxymeter device applied in OSA. The investigators want to give holistic health care for patients and care-givers by this project. In addition, the investigators will build a training environment to provide medical education and training opportunity to teach medical students and clinician the knowledge of pediatric allergic rhinitis and obstructive sleep apnea by caring patients and learning from clinical cases.

Official Title
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Establishing the Collaborative Care Model of Traditional Chinse Medicine and Western Medicine for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.

Conditions
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Pediatric Sleep Apnea

Intervention / Treatment
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* Device: laser acupuncture (RJ laser S/N 1813458)
* Drug: western medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age less than 18 years old Patients with persistent, moderate to severe allergic rhinitis who have been diagnosed by ARIA (2014) diagnostic criteria AHI by polysomnography is >1 and diagnosis with obstructive sleep apnea. Exclusion Criteria: Abnormal craniofacial structure and require surgery. Patients with sleep apnea caused by muscular dysplasia of the upper respiratory tract ( eg. cerebral palsy, Down syndrome, and other congenital muscular hypoplasia). Mental or behavioral abnormalities that cannot cooperate with the researcher, such as schizophrenia, depression, suicidal ideation, etc. Allergy to the treatment previously Any disease or organ system dysfunction that may be life-threatening

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative Care Model of TCM and WM<br>Traditional Chinese Medicine(TCM):laser acupuncture and massage education. Western Medicine (WM):intra-nasal corticosteroid with singulair | Device: laser acupuncture (RJ laser S/N 1813458)<br>* use a low-level-laser acupuncture on acupoint<br>Drug: western medicine<br>* Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD<br>* Other names: intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair);|
| Active Comparator: Western medicine<br>Western Medicine (WM):intra-nasal corticosteroid with singulair | Drug: western medicine<br>* Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD<br>* Other names: intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of mean score of Obstructive Sleep Apnea-18 Questionnaire | Evaluation quality of life pediatric Obstructive Sleep Apnea-18 ,(score:0-108) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of mean score of Sinus and Nasal Quality of Life Survey | questionnaire for quality of life Sinus and Nasal disease (score:5-45) | 8 weeks | 
| The change of mean score of Pediatric Sleep Questionnaire | For quality of sleep (score:0-22) | 8 weeks | 
| The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire) | for hyperactivity -tention deficiency disease (score:0-78) | 8 weeks | 
| Apnea-Hypopnea Index | by polysomnography | 8 weeks | 
| adeonid nasopharnygeal ratio | by X ray Cephalometry | 8 weeks | 
| tonsil size | Friedman Grading Scale (grade 0-4) | 8 weeks | 
| nasal volume | Acoustic rhinometry | 8 weeks AND 12 weeks | 
| adenoid size | Clemen and McMurray grade 1-4 | 8 weeks |