Allergic RhinitisNCT05031793
Establishing the Collaborative Care Model for Pediatric Allergic Rhinitis With Sleep Disorder
A study testing TCM and Western medicine in people with Allergic Rhinitis and Sleep Disorder, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Allergic Rhinitis, Sleep Disorder
- What is being tested?
- TCM and Western medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Feb 2018to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age <18 years old
- ARIA (2014) diagnostic criteria belong to moderate, persistent
- OSA-18 score ≥60
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Rhinitis, Sleep Disorder
- Being tested
- TCM, Western medicine
- Keywords
- Allergic rhinitis, Sleep disorder, Obstructive sleep apnea, Integrative care clinic, TCM, Western medicine
- Medical subject headings
- Rhinitis, Allergic, Sleep Wake Disorders, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCMOther
TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.
Western medicineOther
Western medicine include nasal spray steroid, oral antihistamine
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care of TCM and Western Medicine | Experimental | Not described Receives: Other: TCM; Other: Western medicine |
| Western medicine | Active comparator | Not described Receives: Other: Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of SN-5 scores
SN-5 questionnaire is a tool to evaluate quality of life of sinus and nasal symptoms
Measured: week 8
Secondary outcomes (6)
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.
Measured: week 8
The change of scores of questionnaire of pediatric obstructive sleep apnea (OSA-18)
Obstructive Sleep Apnea-18
Measured: week 8
The change of scores of Pediatric Sleep Questionnaire
Pediatric Sleep Questionnaire is a validated questionnaire to evaluate sleep quality among children
Measured: week 8
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 .
Measured: week 8
dosage of intra-nasal corticosteroid
Weight change of intra-nasal corticosteroid before and after study
Measured: week 8
Apnea-Hyponea index
Apnea-Hyponea index is evaluated by polysomnography
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start8 Feb 2018
- Primary completion31 Dec 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Rong Yen, China Medical University Hospital
- Investigators
- Hung-Rong Yen, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031793
- Sponsor's protocol ID
- CMUH106-REC2-140
- Status last verified
- Aug 2021
- First submitted
- 16 May 2018
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Collaborative Care Model of TCM and Western Medicine for Pediatric Allergic Rhinitis With Sleep Disorder
- ClinicalTrials.gov ID
- NCT05031793
- Acronym / sponsor ID
- CMUH106-REC2-140
- Conditions
- Allergic Rhinitis, Sleep Disorder
- Keywords
- Allergic rhinitis, Sleep disorder, Obstructive sleep apnea, Integrative care clinic, TCM, Western medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care of TCM and Western Medicine | Experimental | Other: TCM, Other: Western medicine |
| Western medicine | Active comparator | Other: Western medicine |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age <18 years old
- ARIA (2014) diagnostic criteria belong to moderate, persistent
- OSA-18 score ≥60
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCMTCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation. | Other | Collaborative Care of TCM and Western Medicine |
| Western medicineWestern medicine include nasal spray steroid, oral antihistamine | Other | Collaborative Care of TCM and Western Medicine, Western medicine |
Primary outcome
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
6 secondary outcomes
The change of scores of Pediatric allergic disease quality of life questionnaire (PADQLQ)
Time frame: week 8
The change of scores of questionnaire of pediatric obstructive sleep apnea (OSA-18)
Time frame: week 8
The change of scores of Pediatric Sleep Questionnaire
Time frame: week 8
The change of hyperactivity-inattentive condition
Time frame: week 8
dosage of intra-nasal corticosteroid
Time frame: week 8
Apnea-Hyponea index
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Rong Yen principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM and Western medicine in people with Allergic Rhinitis and Sleep Disorder, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of SN-5 scores (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.