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

NCT04621513 | Unknown

• 1 other identifier: CMUH109-REC1-089
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The change of mean score of Sinus and Nasal Quality of Life Survey

  8 weeks

• The change of mean score of Pediatric Sleep Questionnaire

  8 weeks

• The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire)

  8 weeks

• Apnea-Hypopnea Index

  8 weeks

• adeonid nasopharnygeal ratio

  8 weeks

Study Arms (2)

Collaborative Care Model of TCM and WM

EXPERIMENTAL

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); Drug: western medicine

Western medicine

ACTIVE COMPARATOR

Western Medicine (WM):intra-nasal corticosteroid with singulair

Drug: western medicine

Interventions

laser acupuncture (RJ laser S/N 1813458) DEVICE

use a low-level-laser acupuncture on acupoint

Collaborative Care Model of TCM and WM

western medicine DRUG

Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD

Also known as: intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair)

Collaborative Care Model of TCM and WM; Western medicine

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University & Hospital

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Interventions

montelukast

Central Study Contacts

Wan-Yu Lai

CONTACT

886-4-22052121; d15779@mail.cmuh.org.tw

Chang-Ching Wei

CONTACT

886-4-22052121; d5522@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Chinese Medicine Pediatrics

Model Details: Parallel Randomized controlled trial

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: November 9, 2020
• Study Start: July 29, 2020
• Primary Completion: December 16, 2021
• Study Completion: December 31, 2022
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)