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

August 30, 2021 updated by: Hung-Rong Yen, China Medical University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collaborative Care of TCM and Western Medicine
Other: TCM
TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.
Other: Western medicine
Western medicine include nasal spray steroid, oral antihistamine
Active Comparator: Western medicine
Other: Western medicine
Western medicine include nasal spray steroid, oral antihistamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of SN-5 scores
Time Frame: week 8
SN-5 questionnaire is a tool to evaluate quality of life of sinus and nasal symptoms
week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Hung-Rong Yen, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

January 20, 2021

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH106-REC2-140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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