Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
Primary Purpose
Pediatric Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
laser acupuncture (RJ laser S/N 1813458)
western medicine
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Age less than 18 years old
- Patients with persistent, moderate to severe allergic rhinitis who have been diagnosed by ARIA (2014) diagnostic criteria
- AHI by polysomnography is >1 and diagnosis with obstructive sleep apnea.
Exclusion Criteria:
- Abnormal craniofacial structure and require surgery.
- Patients with sleep apnea caused by muscular dysplasia of the upper respiratory tract ( eg. cerebral palsy, Down syndrome, and other congenital muscular hypoplasia).
- Mental or behavioral abnormalities that cannot cooperate with the researcher, such as schizophrenia, depression, suicidal ideation, etc.
- Allergy to the treatment previously
- Any disease or organ system dysfunction that may be life-threatening
Sites / Locations
- China Medical University & HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Collaborative Care Model of TCM and WM
Western medicine
Arm Description
Traditional Chinese Medicine(TCM):laser acupuncture and massage education. Western Medicine (WM):intra-nasal corticosteroid with singulair
Western Medicine (WM):intra-nasal corticosteroid with singulair
Outcomes
Primary Outcome Measures
The change of mean score of Obstructive Sleep Apnea-18 Questionnaire
Evaluation quality of life pediatric Obstructive Sleep Apnea-18 ,(score:0-108)
Secondary Outcome Measures
The change of mean score of Sinus and Nasal Quality of Life Survey
questionnaire for quality of life Sinus and Nasal disease (score:5-45)
The change of mean score of Pediatric Sleep Questionnaire
For quality of sleep (score:0-22)
The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire)
for hyperactivity -tention deficiency disease (score:0-78)
Apnea-Hypopnea Index
by polysomnography
adeonid nasopharnygeal ratio
by X ray Cephalometry
tonsil size
Friedman Grading Scale (grade 0-4)
nasal volume
Acoustic rhinometry
adenoid size
Clemen and McMurray grade 1-4
Full Information
NCT ID
NCT04621513
First Posted
July 29, 2020
Last Updated
November 3, 2020
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04621513
Brief Title
Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
Official Title
Establishing the Collaborative Care Model of Traditional Chinse Medicine and Western Medicine for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
December 16, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
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
In this project,the investigators aim to establish a Collaborative Care Model of TCM and Western Medicine to improve the quality of life and symptoms of AR with OSA children and educate care-givers diet and massage information to improve self-care ability and alleviate anxiety for parents. In addition, the investigators will use portable oxymeter to detect the change of SpO2 and respiratory arousal index daily at home and evaluate sensitivity and specificity of portable oxymeter device applied in OSA. The investigators want to give holistic health care for participants and care-givers by this project. In addition, the investigators will build a training environment to provide medical education and training opportunity to teach medical students and clinician the knowledge of pediatric allergic rhinitis and obstructive sleep apnea by caring patients and learning from clinical cases.
Detailed Description
Obstructive sleep apnea (OSA) affects 1-6% among children and has negative influence on day-time school performance and quality of sleep. It also cause failure to thrive,cardiovascular disease,and metabolic disease, which need early intervention. About 6% allergic rhinitis (AR) children would combine with OSA and refractory to treatment and need long-term intra-nasal corticosteroid or surgery if have moderate-severe OSA with adenoid-tonsillar hypertrophy. Some parents considering the side effect of steroid and risk of surgery will search Traditional Chinese Medicine (TCM) for help.
TCM is one kind of preventive medicine by educating people how to keep health by diet and massage. The breathing technique and "Teeth-Buckling and Salivary-Swallowing motion" noted in Inner Canon of the Yellow Emperor, one of the most important ancient Chinese medical text are compatible with myofunctional therapy for OSA. There are several studies revealed improve immune response in allergic rhinitis by TCM and severity of OSA by acupuncture.
In this project, the investigators aim to establish a Collaborative Care Model of TCM and Western Medicine to improve the quality of life and symptoms of AR with OSA children and educate care-givers diet and massage information to improve self-care ability and alleviate anxiety for parents. In addition, the investigators will use portable oxymeter to detect the change of SpO2 and respiratory arousal index daily at home and evaluate sensitivity and specificity of portable oxymeter device applied in OSA. The investigators want to give holistic health care for patients and care-givers by this project. In addition, the investigators will build a training environment to provide medical education and training opportunity to teach medical students and clinician the knowledge of pediatric allergic rhinitis and obstructive sleep apnea by caring patients and learning from clinical cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collaborative Care Model of TCM and WM
Arm Type
Experimental
Arm Description
Traditional Chinese Medicine(TCM):laser acupuncture and massage education. Western Medicine (WM):intra-nasal corticosteroid with singulair
Arm Title
Western medicine
Arm Type
Active Comparator
Arm Description
Western Medicine (WM):intra-nasal corticosteroid with singulair
Intervention Type
Device
Intervention Name(s)
laser acupuncture (RJ laser S/N 1813458)
Intervention Description
use a low-level-laser acupuncture on acupoint
Intervention Type
Drug
Intervention Name(s)
western medicine
Other Intervention Name(s)
intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair)
Intervention Description
Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
Primary Outcome Measure Information:
Title
The change of mean score of Obstructive Sleep Apnea-18 Questionnaire
Description
Evaluation quality of life pediatric Obstructive Sleep Apnea-18 ,(score:0-108)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The change of mean score of Sinus and Nasal Quality of Life Survey
Description
questionnaire for quality of life Sinus and Nasal disease (score:5-45)
Time Frame
8 weeks
Title
The change of mean score of Pediatric Sleep Questionnaire
Description
For quality of sleep (score:0-22)
Time Frame
8 weeks
Title
The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire)
Description
for hyperactivity -tention deficiency disease (score:0-78)
Time Frame
8 weeks
Title
Apnea-Hypopnea Index
Description
by polysomnography
Time Frame
8 weeks
Title
adeonid nasopharnygeal ratio
Description
by X ray Cephalometry
Time Frame
8 weeks
Title
tonsil size
Description
Friedman Grading Scale (grade 0-4)
Time Frame
8 weeks
Title
nasal volume
Description
Acoustic rhinometry
Time Frame
8 weeks AND 12 weeks
Title
adenoid size
Description
Clemen and McMurray grade 1-4
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age less than 18 years old
Patients with persistent, moderate to severe allergic rhinitis who have been diagnosed by ARIA (2014) diagnostic criteria
AHI by polysomnography is >1 and diagnosis with obstructive sleep apnea.
Exclusion Criteria:
Abnormal craniofacial structure and require surgery.
Patients with sleep apnea caused by muscular dysplasia of the upper respiratory tract ( eg. cerebral palsy, Down syndrome, and other congenital muscular hypoplasia).
Mental or behavioral abnormalities that cannot cooperate with the researcher, such as schizophrenia, depression, suicidal ideation, etc.
Allergy to the treatment previously
Any disease or organ system dysfunction that may be life-threatening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Yu Lai
Phone
886-4-22052121
Ext
4561
Email
d15779@mail.cmuh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-Ching Wei
Phone
886-4-22052121
Ext
1925
Email
d5522@mail.cmuh.org.tw
Facility Information:
Facility Name
China Medical University & Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan-Yu Lai, MD
Phone
+886975681928
Email
d15779@mail.cmuh.org.tw
First Name & Middle Initial & Last Name & Degree
Wan-Yu Lai, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
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