Asthma in ChildrenNCT05243667
Research on the Early Warning Model of Children Asthma Acute Attack Based on Wearable Wrist Smart Device of Huami
An observational study of Asthma in Children, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Wearable wrist Smart Device of Huami
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Dec 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with diagnosed asthma.
Who may be able to join
- Clinical diagnosis of asthma.
Who cannot join
- Severe chronic diseases with organ dysfunction and dyspnea.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, 510120
Nanshan Zhong, master, +86-20-83062888, nanshan@vip.163.com
Lihong Sun, master, +86-13719240285, sunlihong9797@126.com
About this study
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Wearable wrist Smart Device of Huami
- Keywords
- Wearable wrist Smart Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable wrist Smart Device of HuamiOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 24 weeks
Secondary outcomes (2)
weight
Weight of enrolled asthmatic patients
Measured: up to 24 weeks
height
Height of enrolled asthmatic patients
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Jun 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI-HONG SUN, Guangzhou Institute of Respiratory Disease
- Investigators
- Qin C Pan, master, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243667
- Sponsor's protocol ID
- GuangzhouIRD-LSUN2
- Status last verified
- Feb 2022
- First submitted
- 15 Aug 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Within six months after the trial complete.
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.
PubMed 31377752Jensen 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.
PubMed 28595614Carew 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.
PubMed 28872938
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Early Warning Model of Children Asthma Acute Attack Based on Wearable Wrist Smart Device of Huami
- ClinicalTrials.gov ID
- NCT05243667
- Acronym / sponsor ID
- GuangzhouIRD-LSUN2
- Conditions
- Asthma in Children
- Keywords
- Wearable wrist Smart Device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 Feb 2022 (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.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with diagnosed asthma.
Key inclusion criteria (1 listed)
- Clinical diagnosis of asthma.
Key exclusion criteria (1 listed)
- Severe chronic diseases with organ dysfunction and dyspnea.
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 |
|---|---|---|
| Wearable wrist Smart Device of HuamiAll 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. | Other | – |
Primary outcome
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
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
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
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
2 secondary outcomes
weight
Time frame: up to 24 weeks
height
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Results publication: PubMed 31377752Kumar 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.
- Results publication: PubMed 28595614Jensen 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.
- Results publication: PubMed 28872938Carew 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.
- Individual participant dataSharing planned: No. Within six months after the trial complete.
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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.
Qin C Pan, master principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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 1 inclusion and 1 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 17 Feb 2022. 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 China. 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 Li h Sun, master (+86 13719240285, sunlihong9797@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243667, which also lists 3 linked publications.
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 17 Feb 2022.