Establishing the Collaborative Care Model of Traditional Chinse Medicine and Western Medicine for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change of mean score of Obstructive Sleep Apnea-18 Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Collaborative Care Model of TCM and WM
Traditional Chinese Medicine(TCM):laser acupuncture and massage education. Western Medicine (WM):intra-nasal corticosteroid with singulair
干预措施: laser acupuncture (RJ laser S/N 1813458) (Device)
Collaborative Care Model of TCM and WM
Traditional Chinese Medicine(TCM):laser acupuncture and massage education. Western Medicine (WM):intra-nasal corticosteroid with singulair
干预措施: western medicine (Drug)
Western medicine
Western Medicine (WM):intra-nasal corticosteroid with singulair
干预措施: western medicine (Drug)
结局指标
主要结局
The change of mean score of Obstructive Sleep Apnea-18 Questionnaire
时间窗: 8 weeks
Evaluation quality of life pediatric Obstructive Sleep Apnea-18 ,(score:0-108)
次要结局
- adeonid nasopharnygeal ratio(8 weeks)
- nasal volume(8 weeks AND 12 weeks)
- adenoid size(8 weeks)
- tonsil size(8 weeks)
- The change of mean score of Sinus and Nasal Quality of Life Survey(8 weeks)
- The change of mean score of Pediatric Sleep Questionnaire(8 weeks)
- The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire)(8 weeks)
- Apnea-Hypopnea Index(8 weeks)
研究者
Wan-Yu Lai
Director, Division of Chinese Medicine Pediatrics
China Medical University Hospital