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Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.

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ClinicalTrials.gov Identifier: NCT04621513
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Wan-Yu Lai, China Medical University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric Sleep Apnea Device: laser acupuncture (RJ laser S/N 1813458) Drug: western medicine Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: 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.
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : December 16, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arms and Interventions
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Arm Intervention/treatment
Experimental: Collaborative Care Model of TCM and WM
Traditional Chinese Medicine(TCM):laser acupuncture and massage education. Western Medicine (WM):intra-nasal corticosteroid with singulair
 Device: laser acupuncture (RJ laser S/N 1813458)
use a low-level-laser acupuncture on acupoint

Drug: western medicine
Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
Other Name: intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair)
Active Comparator: Western medicine
Western Medicine (WM):intra-nasal corticosteroid with singulair
 Drug: western medicine
Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
Other Name: intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair)


Outcome Measures
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Primary Outcome Measures :
  1. The change of mean score of Obstructive Sleep Apnea-18 Questionnaire [ Time Frame: 8 weeks ]
    Evaluation quality of life pediatric Obstructive Sleep Apnea-18 ,(score:0-108)


Secondary Outcome Measures :
  1. The change of mean score of Sinus and Nasal Quality of Life Survey [ Time Frame: 8 weeks ]
    questionnaire for quality of life Sinus and Nasal disease (score:5-45)

  2. The change of mean score of Pediatric Sleep Questionnaire [ Time Frame: 8 weeks ]
    For quality of sleep (score:0-22)

  3. The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire) [ Time Frame: 8 weeks ]
    for hyperactivity -tention deficiency disease (score:0-78)

  4. Apnea-Hypopnea Index [ Time Frame: 8 weeks ]
    by polysomnography

  5. adeonid nasopharnygeal ratio [ Time Frame: 8 weeks ]
    by X ray Cephalometry

  6. tonsil size [ Time Frame: 8 weeks ]
    Friedman Grading Scale (grade 0-4)

  7. nasal volume [ Time Frame: 8 weeks AND 12 weeks ]
    Acoustic rhinometry

  8. adenoid size [ Time Frame: 8 weeks ]
    Clemen and McMurray grade 1-4


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age less than 18 years old
  2. Patients with persistent, moderate to severe allergic rhinitis who have been diagnosed by ARIA (2014) diagnostic criteria
  3. AHI by polysomnography is >1 and diagnosis with obstructive sleep apnea.

Exclusion Criteria:

  1. Abnormal craniofacial structure and require surgery.
  2. Patients with sleep apnea caused by muscular dysplasia of the upper respiratory tract ( eg. cerebral palsy, Down syndrome, and other congenital muscular hypoplasia).
  3. Mental or behavioral abnormalities that cannot cooperate with the researcher, such as schizophrenia, depression, suicidal ideation, etc.
  4. Allergy to the treatment previously
  5. Any disease or organ system dysfunction that may be life-threatening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621513


Contacts
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Contact: Wan-Yu Lai 886-4-22052121 ext 4561 d15779@mail.cmuh.org.tw
Contact: Chang-Ching Wei 886-4-22052121 ext 1925 d5522@mail.cmuh.org.tw

Locations
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Taiwan
China Medical University & Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Wan-Yu Lai, MD    +886975681928    d15779@mail.cmuh.org.tw   
Principal Investigator: Wan-Yu Lai, MD         
Sponsors and Collaborators
China Medical University Hospital
More Information
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Responsible Party: Wan-Yu Lai, Director, Division of Chinese Medicine Pediatrics, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04621513    
Other Study ID Numbers: CMUH109-REC1-089
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Rhinitis, Allergic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Tract Infections
Infections
Nose Diseases
 Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action