Pediatric Sleep Apnea
Conditions
Brief summary
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
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.
Interventions
DEVICElaser acupuncture (RJ laser S/N 1813458)
use a low-level-laser acupuncture on acupoint
DRUGwestern medicine
Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age less than 18 years old 2. Patients with persistent, moderate to severe allergic rhinitis who have been diagnosed by ARIA (2014) diagnostic criteria 3. AHI by polysomnography is \>1 and diagnosis with obstructive sleep apnea.
Exclusion criteria
1. Abnormal craniofacial structure and require surgery. 2. Patients with sleep apnea caused by muscular dysplasia of the upper respiratory tract ( eg. cerebral palsy, Down syndrome, and other congenital muscular hypoplasia). 3. Mental or behavioral abnormalities that cannot cooperate with the researcher, such as schizophrenia, depression, suicidal ideation, etc. 4. Allergy to the treatment previously 5. Any disease or organ system dysfunction that may be life-threatening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of mean score of Obstructive Sleep Apnea-18 Questionnaire | 8 weeks | Evaluation quality of life pediatric Obstructive Sleep Apnea-18 ,(score:0-108) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of mean score of Pediatric Sleep Questionnaire | 8 weeks | For quality of sleep (score:0-22) |
| The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire) | 8 weeks | for hyperactivity -tention deficiency disease (score:0-78) |
| Apnea-Hypopnea Index | 8 weeks | by polysomnography |
| The change of mean score of Sinus and Nasal Quality of Life Survey | 8 weeks | questionnaire for quality of life Sinus and Nasal disease (score:5-45) |
| tonsil size | 8 weeks | Friedman Grading Scale (grade 0-4) |
| nasal volume | 8 weeks AND 12 weeks | Acoustic rhinometry |
| adenoid size | 8 weeks | Clemen and McMurray grade 1-4 |
| adeonid nasopharnygeal ratio | 8 weeks | by X ray Cephalometry |
Countries
Taiwan
Contacts
Primary ContactWan-Yu Lai
Backup ContactChang-Ching Wei
Outcome results
None listed