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Completed

NCT Number: NCT05031793

Establishing the Collaborative Care Model 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCM

Other

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

Western medicine

Other

Western medicine include nasal spray steroid, oral antihistamine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

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

    Time frame: week 8

    Obstructive Sleep Apnea-18

  3. 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

  4. 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 .

  5. dosage of intra-nasal corticosteroid

    Time frame: week 8

    Weight change of intra-nasal corticosteroid before and after study

  6. Apnea-Hyponea index

    Time frame: week 12

    Apnea-Hyponea index is evaluated by polysomnography

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 2, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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