Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
NCT ID: NCT04621513
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-07-29
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Collaborative Care Model of TCM and WM
Traditional Chinese Medicine(TCM):laser acupuncture and massage education. Western Medicine (WM):intra-nasal corticosteroid with singulair
laser acupuncture (RJ laser S/N 1813458)
use a low-level-laser acupuncture on acupoint
western medicine
Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
Western medicine
Western Medicine (WM):intra-nasal corticosteroid with singulair
western medicine
Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
Interventions
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laser acupuncture (RJ laser S/N 1813458)
use a low-level-laser acupuncture on acupoint
western medicine
Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
6 Months
18 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Wan-Yu Lai
Director, Division of Chinese Medicine Pediatrics
Locations
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China Medical University & Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Wan-Yu Lai, MD
Role: primary
Other Identifiers
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CMUH109-REC1-089
Identifier Type: -
Identifier Source: org_study_id