Research on the Early Warning Model of Children Asthma Acute Attack Based on Wearable Wrist Smart Device of Huami

Asthma in Children Clinical Trial

Official title:

Research on the Early Warning Model of Children Asthma Acute Attack Based on Wearable Wrist Smart Device of Huami

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243667
• Other study ID #: GuangzhouIRD-LSUN2
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2022
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Li h Sun, master
• Phone: +86 13719240285
• Email: sunlihong9797[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

Inclusion Criteria:

Clinical diagnosis of asthma.

Exclusion Criteria:

Severe chronic diseases with organ dysfunction and dyspnea.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• Wearable wrist Smart Device of Huami
All enrolled patients underwent continuous monitoring by wearing huami blood oxygen testing equipment, and signed the informed consent for the clinical trial.Smart wrist wristbands will be issued, and patient information will be bound to the "Migang Health" platform, and clinical trial doctors will improve relevant personal information and clinical data.After binding to the APP "Migu Health", you can start collecting and recording dynamic data such as peripheral blood oxygen saturation, heart rate, exercise steps, sleep data, etc., and upload the data once a day.

Locations

Country	Name	City	State
China	Guangzhou institute of respiratory disease	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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/s41390-019-05 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	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
Primary	blood oxygen	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
Primary	exercise	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
Primary	sleep	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	weight	Weight of enrolled asthmatic patients	up to 24 weeks
Secondary	height	Height of enrolled asthmatic patients	up to 24 weeks