Clinical trial NCT05031793: Establishing the Collaborative Care Model for Pediatric Allergic Rhinitis With Sleep Disorder
Official title: Establishing the Collaborative Care Model of TCM and Western Medicine for Pediatric Allergic Rhinitis With Sleep Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Sleep Disorder
Keywords: Allergic rhinitis
Sleep disorder
Obstructive sleep apnea
Integrative care clinic
TCM
Western medicine
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 35
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. age \<18 years old
2. ARIA (2014) diagnostic criteria belong to moderate, persistent
3. OSA-18 score ≥60

Exclusion Criteria:

1. cranial-facial anomaly
2. secondary obstruction sleep apnea due to muscle weakness of upper airway, such as Down syndrome or cerebral palsy
3. psychiatric disease or behavior disorder
4. allergy to TCM or ordinary western medicine treatment
5. asthma

Primary outcomes:
measure: The change of SN-5 scores
timeFrame: week 8
Secondary outcomes:
measure: The change of scores of Pediatric allergic disease quality of life questionnaire (PADQLQ)
timeFrame: week 8
measure: The change of scores of questionnaire of pediatric obstructive sleep apnea (OSA-18)
timeFrame: week 8
measure: The change of scores of Pediatric Sleep Questionnaire
timeFrame: week 8
measure: The change of hyperactivity-inattentive condition
timeFrame: week 8
measure: dosage of intra-nasal corticosteroid
timeFrame: week 8
measure: Apnea-Hyponea index
timeFrame: week 12
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Hung-Rong Yen
role: PRINCIPAL_INVESTIGATOR
References: