- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05243667
Research on the Early Warning Model of Children Asthma Acute Attack Based on Wearable Wrist Smart Device of Huami
February 7, 2022 updated by: LI-HONG SUN, Guangzhou Institute of Respiratory Disease
Childhood asthma is the most common chronic respiratory disease in childhood.
The essence of asthma is chronic airway inflammation and airway hyperresponsiveness.The physiological characteristics of children and adults are very different, and the compensatory ability is very strong.
There are often no obvious symptoms at the early stage of attack, or only intermittent or persistent cough of different degrees, without typical chest tightness and asthma.However, at this time, certain physiological indicators such as blood oxygen, heart rate, respiratory rate may have been significantly abnormal.If the disease continues to deteriorate and progresses to decompensation, it can quickly move from an asymptomatic state to a failure stage.Therefore, dynamic and accurate acquisition of real-time vital signs and assessment is of great significance for early warning and improvement of prognosis of asthma attacks in children.Intelligent wearable devices can be used to acquire real-time physiological index data of users, such as heart rate, blood oxygen, exercise and sleep dynamic data.An in-depth analysis of long-term and multi-scene dynamic data before and after asthma attacks can establish an early warning model for children with acute asthma attacks by wearable wrist smart devices, which may provide important help for severity assessment, follow-up tracking and out-of-hospital prevention and control of the disease.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
this project is selected 200 cases of children with asthma diagnosis definitely, collection and heart rate, blood oxygen, exercise and sleep dynamic data, followed up for 3 to 6 months (at least 3 months), records of clinical asthma attacks and clinical data, through the cloud data analysis and deep learning, analysis of children with asthma attacks and multiple physiological parameters (heart rate, blood oxygen, movement and the dynamic data of sleep, etc.), the connection between the building of asthma early warning and illness severity hierarchical evaluation model.Then choose 200 cases of diagnosis in clinical practice to determine follow-up, patients with asthma children to observe to verify the exactness of the model of asthma attack early warning, and according to the collected data to further improve, calibration model, designed to provide children with family members and medical personnel of an asthma attack warning and follow-up management wearable auxiliary equipment and management platform.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li h Sun, master
- Phone Number: +86 13719240285
- Email: sunlihong9797@126.com
Study Contact Backup
- Name: Sun K Huang, master
- Phone Number: +86 13512750833
- Email: amwkdga@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Recruiting
- Guangzhou Institute of Respiratory Disease
-
Contact:
- Nanshan Zhong, master
- Phone Number: +86-20-83062888
- Email: nanshan@vip.163.com
-
Contact:
- Lihong Sun, master
- Phone Number: +86-13719240285
- Email: sunlihong9797@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with diagnosed asthma.
Description
Inclusion Criteria:
Clinical diagnosis of asthma.
Exclusion Criteria:
Severe chronic diseases with organ dysfunction and dyspnea.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: up to 24 weeks
|
Follow-up monitoring of confirmed asthma patients was conducted based on intelligent wearable devices, and multiple physiological parameters such as heart rate were collected in the pre-attack, attack and remission stages
|
up to 24 weeks
|
|
blood oxygen
Time Frame: up to 24 weeks
|
Follow-up monitoring of confirmed asthma patients was conducted based on intelligent wearable devices, and blood oxygen were collected in the pre-attack, attack and remission stages
|
up to 24 weeks
|
|
exercise
Time Frame: up to 24 weeks
|
Follow-up monitoring of confirmed asthma patients was conducted based on intelligent wearable devices, and exercise were collected in the pre-attack, attack and remission stages
|
up to 24 weeks
|
|
sleep
Time Frame: up to 24 weeks
|
Follow-up monitoring of confirmed asthma patients was conducted based on intelligent wearable devices, and sleep were collected in the pre-attack, attack and remission stages
|
up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight
Time Frame: up to 24 weeks
|
Weight of enrolled asthmatic patients
|
up to 24 weeks
|
|
height
Time Frame: up to 24 weeks
|
Height of enrolled asthmatic patients
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Qin C Pan, master, Guangzhou Institute of Respiratory Disease
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kumar N, Akangire G, Sullivan B, Fairchild K, Sampath V. Continuous vital sign analysis for predicting and preventing neonatal diseases in the twenty-first century: big data to the forefront. Pediatr Res. 2020 Jan;87(2):210-220. doi: 10.1038/s41390-019-0527-0. Epub 2019 Aug 4.
- Jensen CS, Aagaard H, Olesen HV, Kirkegaard H. A multicentre, randomised intervention study of the Paediatric Early Warning Score: study protocol for a randomised controlled trial. Trials. 2017 Jun 8;18(1):267. doi: 10.1186/s13063-017-2011-7.
- Carew C, Cox DW. Laps or lengths? The effects of different exercise programs on asthma control in children. J Asthma. 2018 Aug;55(8):877-881. doi: 10.1080/02770903.2017.1373806. Epub 2017 Oct 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Anticipated)
December 30, 2024
Study Completion (Anticipated)
December 30, 2024
Study Registration Dates
First Submitted
August 15, 2021
First Submitted That Met QC Criteria
February 7, 2022
First Posted (Actual)
February 17, 2022
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GuangzhouIRD-LSUN2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Within six months after the trial complete.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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