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

Allergic Rhinitis Clinical Trial

Official title:

Establishing the Collaborative Care Model of TCM and Western Medicine for Pediatric Allergic Rhinitis With Sleep Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031793
• Other study ID #: CMUH106-REC2-140
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: January 20, 2021

Study information

• Verified date: August 2021
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 20, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Disease
• Parasomnias
• Rhinitis
• Rhinitis, Allergic
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• TCM
TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.
• Western medicine
Western medicine include nasal spray steroid, oral antihistamine

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of SN-5 scores	SN-5 questionnaire is a tool to evaluate quality of life of sinus and nasal symptoms	week 8
Secondary	The change of scores of Pediatric allergic disease quality of life questionnaire (PADQLQ)	Pediatric allergic disease quality of life questionnaire (PADQLQ) is a validated tool to evaluate quality of life of pediatric allergic disease.	week 8
Secondary	The change of scores of questionnaire of pediatric obstructive sleep apnea (OSA-18)	Obstructive Sleep Apnea-18	week 8
Secondary	The change of scores of Pediatric Sleep Questionnaire	Pediatric Sleep Questionnaire is a validated questionnaire to evaluate sleep quality among children	week 8
Secondary	The change of hyperactivity-inattentive condition	SNAP-IV is a validated tool designed by Swanson, Nolan and Pelham ,is the questionnaire used to evaluate hyperactivity-inattentive condition .	week 8
Secondary	dosage of intra-nasal corticosteroid	Weight change of intra-nasal corticosteroid before and after study	week 8
Secondary	Apnea-Hyponea index	Apnea-Hyponea index is evaluated by polysomnography	week 12