Clinical trial NCT04621513: Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
Official title: Establishing the Collaborative Care Model of Traditional Chinse Medicine and Western Medicine for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Sleep Apnea
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of mean score of Obstructive Sleep Apnea-18 Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: The change of mean score of Sinus and Nasal Quality of Life Survey
timeFrame: 8 weeks
measure: The change of mean score of Pediatric Sleep Questionnaire
timeFrame: 8 weeks
measure: The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire)
timeFrame: 8 weeks
measure: Apnea-Hypopnea Index
timeFrame: 8 weeks
measure: adeonid nasopharnygeal ratio
timeFrame: 8 weeks
measure: tonsil size
timeFrame: 8 weeks
measure: nasal volume
timeFrame: 8 weeks AND 12 weeks
measure: adenoid size
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University & Hospital
Study officials:
References: