Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.

Last updated: November 3, 2020
Sponsor: China Medical University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Allergy

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT04621513
CMUH109-REC1-089
  • Ages 6-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age less than 18 years old
  2. Patients with persistent, moderate to severe allergic rhinitis who have been diagnosedby ARIA (2014) diagnostic criteria
  3. AHI by polysomnography is >1 and diagnosis with obstructive sleep apnea.

Exclusion

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 asschizophrenia, depression, suicidal ideation, etc.
  4. Allergy to the treatment previously
  5. Any disease or organ system dysfunction that may be life-threatening

Study Design

Total Participants: 60
Study Start date:
July 29, 2020
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • China Medical University & Hospital

    Taichung, 40447
    Taiwan

    Active - Recruiting

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