NCT05031793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

May 16, 2018

Last Update Submit

August 30, 2021

Conditions

Allergic RhinitisSleep Disorder

Keywords

Allergic rhinitisSleep disorderObstructive sleep apneaIntegrative care clinicTCMWestern medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The change of scores of Pediatric allergic disease quality of life questionnaire (PADQLQ)

    week 8

  • The change of scores of questionnaire of pediatric obstructive sleep apnea (OSA-18)

    week 8

  • The change of scores of Pediatric Sleep Questionnaire

    week 8

  • The change of hyperactivity-inattentive condition

    week 8

  • dosage of intra-nasal corticosteroid

    week 8

  • +1 more secondary outcomes

Study Arms (2)

Collaborative Care of TCM and Western Medicine

EXPERIMENTAL
Other: TCMOther: Western medicine

Western medicine

ACTIVE COMPARATOR
Other: Western medicine

Interventions

TCMOTHER

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

Collaborative Care of TCM and Western Medicine
Western medicineOTHER

Western medicine include nasal spray steroid, oral antihistamine

Collaborative Care of TCM and Western MedicineWestern medicine

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Rhinitis, AllergicSleep Wake DisordersSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Hung-Rong Yen

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

May 16, 2018

First Posted

September 2, 2021

Study Start

February 8, 2018

Primary Completion

December 31, 2020

Study Completion

January 20, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations

TW(1)