Establishing the Collaborative Care Model for Pediatric Allergic Rhinitis With Sleep Disorder

NCT ID: NCT05031793

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2021-01-20

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.

Conditions

Allergic Rhinitis; Sleep Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Collaborative Care of TCM and Western Medicine

Group Type: EXPERIMENTAL

TCM

Intervention Type: OTHER

TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.

Western medicine

Intervention Type: OTHER

Western medicine include nasal spray steroid, oral antihistamine

Western medicine

Group Type: ACTIVE_COMPARATOR

Western medicine

Intervention Type: OTHER

Western medicine include nasal spray steroid, oral antihistamine

Interventions

TCM

TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.

Intervention Type: OTHER

Western medicine

Western medicine include nasal spray steroid, oral antihistamine

Intervention Type: OTHER

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hung-Rong Yen

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hung-Rong Yen

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH106-REC2-140

Identifier Type: -

Identifier Source: org_study_id