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

Establishing the Collaborative Care Model of Traditional Chinse Medicine and Western Medicine for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.

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.

Study Overview

• Status: Unknown
• Conditions: Pediatric Sleep Apnea
• Intervention / Treatment: Device: laser acupuncture (RJ laser S/N 1813458); Drug: western medicine

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University & Hospital
    • Contact: Wan-Yu Lai, MD; Phone Number: +886975681928; Email: d15779@mail.cmuh.org.tw
    • Principal Investigator: Wan-Yu Lai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of mean score of Obstructive Sleep Apnea-18 Questionnaire	Evaluation quality of life pediatric Obstructive Sleep Apnea-18 ,(score:0-108)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 weeks
The change of mean score of Pediatric Sleep Questionnaire	For quality of sleep (score:0-22)	8 weeks
The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire)	for hyperactivity -tention deficiency disease (score:0-78)	8 weeks
Apnea-Hypopnea Index	by polysomnography	8 weeks
adeonid nasopharnygeal ratio	by X ray Cephalometry	8 weeks
tonsil size	Friedman Grading Scale (grade 0-4)	8 weeks
nasal volume	Acoustic rhinometry	8 weeks AND 12 weeks
adenoid size	Clemen and McMurray grade 1-4	8 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 29, 2020
• Primary Completion (ANTICIPATED): December 16, 2021
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (ACTUAL): November 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: CMUH109-REC1-089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No