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

Primary Purpose

Allergic Rhinitis, Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TCM
Western medicine
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic rhinitis, Sleep disorder, Obstructive sleep apnea, Integrative care clinic, TCM, Western medicine

Eligibility Criteria

0 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Collaborative Care of TCM and Western Medicine

Western medicine

Arm Description

Outcomes

Primary Outcome Measures

The change of SN-5 scores
SN-5 questionnaire is a tool to evaluate quality of life of sinus and nasal symptoms

Secondary Outcome Measures

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.
The change of scores of questionnaire of pediatric obstructive sleep apnea (OSA-18)
Obstructive Sleep Apnea-18
The change of scores of Pediatric Sleep Questionnaire
Pediatric Sleep Questionnaire is a validated questionnaire to evaluate sleep quality among children
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 .
dosage of intra-nasal corticosteroid
Weight change of intra-nasal corticosteroid before and after study
Apnea-Hyponea index
Apnea-Hyponea index is evaluated by polysomnography

Full Information

First Posted
May 16, 2018
Last Updated
August 30, 2021
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05031793
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Sleep Disorder
Keywords
Allergic rhinitis, Sleep disorder, Obstructive sleep apnea, Integrative care clinic, TCM, Western medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Care of TCM and Western Medicine
Arm Type
Experimental
Arm Title
Western medicine
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
TCM
Intervention Description
TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.
Intervention Type
Other
Intervention Name(s)
Western medicine
Intervention Description
Western medicine include nasal spray steroid, oral antihistamine
Primary Outcome Measure Information:
Title
The change of SN-5 scores
Description
SN-5 questionnaire is a tool to evaluate quality of life of sinus and nasal symptoms
Time Frame
week 8
Secondary Outcome Measure Information:
Title
The change of scores of Pediatric allergic disease quality of life questionnaire (PADQLQ)
Description
Pediatric allergic disease quality of life questionnaire (PADQLQ) is a validated tool to evaluate quality of life of pediatric allergic disease.
Time Frame
week 8
Title
The change of scores of questionnaire of pediatric obstructive sleep apnea (OSA-18)
Description
Obstructive Sleep Apnea-18
Time Frame
week 8
Title
The change of scores of Pediatric Sleep Questionnaire
Description
Pediatric Sleep Questionnaire is a validated questionnaire to evaluate sleep quality among children
Time Frame
week 8
Title
The change of hyperactivity-inattentive condition
Description
SNAP-IV is a validated tool designed by Swanson, Nolan and Pelham ,is the questionnaire used to evaluate hyperactivity-inattentive condition .
Time Frame
week 8
Title
dosage of intra-nasal corticosteroid
Description
Weight change of intra-nasal corticosteroid before and after study
Time Frame
week 8
Title
Apnea-Hyponea index
Description
Apnea-Hyponea index is evaluated by polysomnography
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age <18 years old ARIA (2014) diagnostic criteria belong to moderate, persistent OSA-18 score ≥60 Exclusion Criteria: cranial-facial anomaly secondary obstruction sleep apnea due to muscle weakness of upper airway, such as Down syndrome or cerebral palsy psychiatric disease or behavior disorder allergy to TCM or ordinary western medicine treatment asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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

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