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

Pediatric Sleep Apnea Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04621513
• Other study ID #: CMUH109-REC1-089
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: China Medical University Hospital
• Contact: Wan-Yu Lai
• Phone: 886-4-22052121
• Email: d15779[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Pediatric Sleep Apnea
• Rhinitis
• Rhinitis, Allergic
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University & Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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