Pediatric Sleep ApneaNCT04621513
Collaborative Care Model for Allergic Rhinitis With Obstructive Sleep Apnea From Prevention to Treatment.
A study testing laser acupuncture (RJ laser S/N 1813458) and western medicine in people with Pediatric Sleep Apnea, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Pediatric Sleep Apnea
- What is being tested?
- laser acupuncture (RJ laser S/N 1813458) and western medicine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jul 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University & Hospital
Taichung, 40447
Wan-Yu Lai, MD, +886975681928, d15779@mail.cmuh.org.tw
Wan-Yu Lai, MD
About this study
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.
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.
Read the 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.
- Conditions
- Pediatric Sleep Apnea
- Being tested
- laser acupuncture (RJ laser S/N 1813458), western medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupuncture (RJ laser S/N 1813458)Device
use a low-level-laser acupuncture on acupoint
western medicineDrug
Also called intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair)
Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: laser acupuncture (RJ laser S/N 1813458); Drug: western medicine |
| Western medicine | Active comparator | Western Medicine (WM):intra-nasal corticosteroid with singulair Receives: Drug: western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of mean score of Obstructive Sleep Apnea-18 Questionnaire
Evaluation quality of life pediatric Obstructive Sleep Apnea-18 ,(score:0-108)
Measured: 8 weeks
Secondary outcomes (8)
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)
Measured: 8 weeks
The change of mean score of Pediatric Sleep Questionnaire
For quality of sleep (score:0-22)
Measured: 8 weeks
The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire)
for hyperactivity -tention deficiency disease (score:0-78)
Measured: 8 weeks
Apnea-Hypopnea Index
by polysomnography
Measured: 8 weeks
adeonid nasopharnygeal ratio
by X ray Cephalometry
Measured: 8 weeks
tonsil size
Friedman Grading Scale (grade 0-4)
Measured: 8 weeks
nasal volume
Acoustic rhinometry
Measured: 8 weeks AND 12 weeks
adenoid size
Clemen and McMurray grade 1-4
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start29 Jul 2020
- Primary completion16 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Yu Lai, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621513
- Sponsor's protocol ID
- CMUH109-REC1-089
- Status last verified
- Nov 2020
- First submitted
- 29 Jul 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04621513
- Acronym / sponsor ID
- CMUH109-REC1-089
- Conditions
- Pediatric Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 16 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care Model of TCM and WM | Experimental | Device: laser acupuncture (RJ laser S/N 1813458), Drug: western medicineTraditional Chinese Medicine(TCM):laser acupuncture and massage education. Western Medicine (WM):intra-nasal corticosteroid with singulair |
| Western medicine | Active comparator | Drug: western medicineWestern Medicine (WM):intra-nasal corticosteroid with singulair |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser acupuncture (RJ laser S/N 1813458)use a low-level-laser acupuncture on acupoint | Device | Collaborative Care Model of TCM and WM |
| western medicineAlso: intra-nasal corticosteroid(AVAMYS) with Montelukast (singulair)Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD | Drug | Collaborative Care Model of TCM and WM, Western medicine |
Primary outcome
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)
8 secondary outcomes
The change of mean score of Sinus and Nasal Quality of Life Survey
Time frame: 8 weeks
The change of mean score of Pediatric Sleep Questionnaire
Time frame: 8 weeks
The change of mean score of SNAP IV ( Swanson, Nolan and Pelham questionnaire)
Time frame: 8 weeks
Apnea-Hypopnea Index
Time frame: 8 weeks
adeonid nasopharnygeal ratio
Time frame: 8 weeks
tonsil size
Time frame: 8 weeks
nasal volume
Time frame: 8 weeks AND 12 weeks
adenoid size
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: No
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Photobiomodulation for Pediatric Hypertrophic Tonsils
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Not yet recruitingObservational study
Development of a Multimodal Deep Learning Model for Pediatric Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture (RJ laser S/N 1813458) and western medicine in people with Pediatric Sleep Apnea, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Yu Lai (886-4-22052121 ext. 4561, d15779@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of mean score of Obstructive Sleep Apnea-18 Questionnaire (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.