China Medical University Hospital
Taichung, Taiwan
NCT Number: NCT05031793
The purpose of study is to compared the impact of the integrative care clinic to ordinary western medicine among patients of moderate persistent allergic rhinitis combined with sleep disorder and establishing the collaborative care model of TCM and western medicine for pediatric allergic rhinitis with sleep disorder.
Investigators invited children aged below 18 years old to the integrative care clinic as experimental group, who have persistent moderate allergic rhinitis, more than 60 scores of the OSA-18 sleep questionnaire, and can accept integrative therapy. The controlled group is patients who receive ordinary western treatment. Investigators compare these two groups by questionnaires of OSA-18,SN-5, PADQLQ,SNAP-IV, the dose of nasal corticosteroid , and polysomnography.
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Notify Me0 year–18 year
All sexes
Interventional
Not applicable
Taichung, Taiwan
In Taiwan, there are many patients suffer from pediatric allergic rhinitis and lead to the medical heavy budget. The persistent symptoms would cause sleep disorder or complicated with pediatric obstructive sleep apnea. It would affect the growth development ,attention deficiency, or psychiatric cognition problems. Obstructive sleep apnea for a long time would result in cardiovascular, endocrine, and metabolic complications if not well-treated.
Patients of allergic rhinitis combined with sleep disorder are classified to moderate persistent type by ARIA, who are intractable to ordinary treatment. Investigators invited them to the integrative care clinic. In addition to the ordinary western medicine, the therapies in the integrative care clinic included herbal medicine, nasal aerosol inhalation, acupuncture, and health care education. The purpose of our study is to compared the impact of the integrative care clinic to ordinary western medicine among patients of moderate persistent allergic rhinitis combined with sleep disorder and establishing the collaborative care model of TCM and western medicine for pediatric allergic rhinitis with sleep disorder.
Investigators invited children aged below 18 years old to the integrative care clinic as experimental group, who have persistent moderate allergic rhinitis, more than 60 scores of the OSA-18 sleep questionnaire, and can accept integrative therapy. The controlled group is patients who receive ordinary western treatment. Investigators compare these two groups by questionnaires of OSA-18,SN-5, PADQLQ,SNAP-IV, the dose of nasal corticosteroid , and polysomnography.
Investigators hoped to prove the effect of integrative care clinic and to upgrade the quality and efficacy of the treatment among persistent moderate allergic rhinitis children.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.
Western medicine include nasal spray steroid, oral antihistamine
Time frame: week 8
SN-5 questionnaire is a tool to evaluate quality of life of sinus and nasal symptoms
Time frame: week 8
Pediatric allergic disease quality of life questionnaire (PADQLQ) is a validated tool to evaluate quality of life of pediatric allergic disease.
Time frame: week 8
Obstructive Sleep Apnea-18
Time frame: week 8
Pediatric Sleep Questionnaire is a validated questionnaire to evaluate sleep quality among children
Time frame: week 8
SNAP-IV is a validated tool designed by Swanson, Nolan and Pelham ,is the questionnaire used to evaluate hyperactivity-inattentive condition .
Time frame: week 8
Weight change of intra-nasal corticosteroid before and after study
Time frame: week 12
Apnea-Hyponea index is evaluated by polysomnography
China Medical University Hospital
Other
Establishing the Collaborative Care Model of TCM and Western Medicine for Pediatric Allergic Rhinitis With Sleep Disorder
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