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

Sponsor
Guangzhou Institute of Respiratory Disease (Other)
Overall Status
Recruiting
CT.gov ID
NCT05243667
Collaborator
(none)
200
1
43
4.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Wearable wrist Smart Device of Huami

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Research on the Early Warning Model of Children Asthma Acute Attack Based on Wearable Wrist Smart Device of Huami
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Heart rate [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

  2. blood oxygen [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

  3. exercise [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

  4. sleep [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

Secondary Outcome Measures

  1. weight [up to 24 weeks]

    Weight of enrolled asthmatic patients

  2. height [up to 24 weeks]

    Height of enrolled asthmatic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Clinical diagnosis of asthma.

Exclusion Criteria:

Severe chronic diseases with organ dysfunction and dyspnea.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangzhou institute of respiratory disease Guangzhou Guangdong China 510120

Sponsors and Collaborators

  • Guangzhou Institute of Respiratory Disease

Investigators

  • Principal Investigator: Qin C Pan, master, Guangzhou Institute of Respiratory Disease

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LI-HONG SUN, Clinical Professor, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier:
NCT05243667
Other Study ID Numbers:
  • GuangzhouIRD-LSUN2
First Posted:
Feb 17, 2022
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by LI-HONG SUN, Clinical Professor, Guangzhou Institute of Respiratory Disease
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2022