NCT05243667

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

3.6 years

First QC Date

August 15, 2021

Last Update Submit

February 7, 2022

Conditions

Keywords

Wearable wrist Smart Device

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • weight

    up to 24 weeks

  • height

    up to 24 weeks

Interventions

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.

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with diagnosed asthma.

You may qualify if:

  • Clinical diagnosis of asthma.

You may not qualify if:

  • Severe chronic diseases with organ dysfunction and dyspnea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (3)

  • 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 Officials

  • Qin C Pan, master

    Guangzhou Institute of Respiratory Disease

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun K Huang, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 15, 2021

First Posted

February 17, 2022

Study Start

June 1, 2021

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Within six months after the trial complete.

Locations