AsthmaNCT05659225
Telemedicine System and Intelligent Monitoring System Construction of Pediatric Asthma Based on the Electronic Stethoscope
A study testing Electronic Stethoscope and Standard treatment according to GINA(2019) in people with Asthma, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
The purpose of this study is to retrofit the existing electronic stethoscope, improve the quality and efficiency of signal acquisition and the intelligent degree of information processing, decrease the manual action of electronic stethoscopes implemented by parents of asthma children, simplify the process of data… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- Electronic Stethoscope and Standard treatment according to GINA(2019)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" in the respiratory clinic of Shanghai Children's Medical Center from January 2023 to January 2025
- Out-patient, female or male, 3 years old≤ age < 6 years old
- long-term maintenance therapy with inhaled glucocorticoids or concomitant leukotriene receptor antagonists
- Equipped with a household atomizer or spacer, it can afford the inhalation therapy of short-acting β2 receptor agonists (SABA) at home
- The subjects or subjects' caregiver must have a smart phone with Android or Harmony system at their disposal
- The guardian agrees to participate in the study and signs the informed consent form
Who cannot join
- Acute exacerbation of asthma 30 days before enrollment (receive short-term prednisone treatment, emergency department visit or hospitalization due to acute asthma attacks)
- Other chronic lung diseases, cardiovascular diseases, blood system diseases, immunodeficiency diseases, neurological diseases, genetic or chromosomal abnormalities and other underlying diseases
- Patients or their caregivers can't complete the collection of breath sound
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
Yong Yin, PhD, 8618930830705, yinyong9999@163.com
About this study
The purpose of this study is to retrofit the existing electronic stethoscope, improve the quality and efficiency of signal acquisition and the intelligent degree of information processing, decrease the manual action of electronic stethoscopes implemented by parents of asthma children, simplify the process of data transfer and the user's operational cost using signal processing, artificial intelligence technology, thus decreasing the feedback cycle between patients and clinicians. Eventually, we will construct an intelligent monitoring system based on the modified electronic stethoscope and explore the interactive remote management approaches on children's asthma at the same time, thus achieving revolutionized remote management of asthma.
Read the detailed description
(1) The design of hardware and software of the intelligent electronic stethoscope This project will optimize and develop the software and hardware equipment of electronic stethoscope according to the shortcomings of existing electronic stethoscopes.
- Get high-quality breath sound data through integrated ECG sensor and algorithms for denoising and the separation of heart sound and lung sound
- Develop algorithms and corresponding frameworks for visualization of breath sounds and mining of key information
- Develop algorithms for automatic recognition of abnormal breath sounds
- Transfer breath sound data efficiently and reliably based on the encoding-decoding architecture
- Optimize the breath sound data transmission process
- Construct the remote diagnosis and treatment methods and monitoring system for childhood asthma preliminary (2) The effect of telemedicine system and intelligent monitoring system based on intelligent stethoscope on children with asthma Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as baseline medical condition will be collected by the investigators. The subject will be randomly assigned to the control group and the electronic stethoscope group. The patient's caregiver who was assigned to the electronic stethoscope group will be instructed to install the electronic stethoscope developed by our team and its accessories, then they will be trained by investigators on how to use the electronic stethoscope.
During the study, patients will receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". If patients develop upper respiratory tract symptoms without fever, the investigator will give corresponding guidance to the control group and the electronic stethoscope group. If fever develops, it is recommended that patients directly go to the emergency department.
All patients' caregiver will be prompted to finish the test for respiratory and asthma control in kids (TRACK) every month. Patient's caregiver assigned to the electronic stethoscope group will also need to complete the collection, data upload and sharing of patient's breath sounds at least once a month to confirm that the electronic stethoscope is worked correctly.
After enrollment, patients will be requested to visit Shanghai Children's Medical Center at month 3, 6, 9, 12. During each onsite visit, subjects will receive lung function (≥4 years) and FENO tests and fill out the questionnaire regarding the number of asthma-related outpatient emergency department visits, asthma-related hospitalizations, SABA and systemic glucocorticoid use, missed work and school misses, and asthma-related medical expenses in the past 3 months. At 6- and 12-month's visit, pediatric asthma caregiver's quality of Life questionnaire (PACQLQ) needs to be completed at the same time.
- Conditions
- Asthma
- Being tested
- Electronic Stethoscope, Standard treatment according to GINA(2019)
- Keywords
- Pediatric, Asthma Control, Electronic Stethoscope
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic StethoscopeDevice
Also called study-specified asthma device program
Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. The patient's caregiver who was assigned to the electronic stethoscope group will be instructed to install the electronic stethoscope developed by our team and its accessories, then they will be trained by investigators on how to use the electronic stethoscope.
Standard treatment according to GINA(2019)Other
Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. The patient's caregiver who was assigned to the control group will receieve standard treatment according to GINA(2019).
| Study group | Role | What they receive |
|---|---|---|
| electronic stethoscope group | Other | During the study, subjects who diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" will be assigned to the control group and the electronic stethoscope group, and receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". The patient's caregiver will be instructed to use an electronic stethoscope to coordinate treatment and complete follow-up. Receives: Device: Electronic Stethoscope; Other: Standard treatment according to GINA(2019) |
| control group | Other | During the study, subjects who diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" will be assigned to the control group and the electronic stethoscope group, and receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". Receives: Other: Standard treatment according to GINA(2019) |
What is being measured
The primary outcome is the main question the study is designed to answer.
visits of asthma-related unplanned emergency department
Subjects will fill out a questionnaire to provide the number of unscheduled emergency department visits related to asthma (except for routine asthma follow-up visits every 3 months).
Measured: 1 year
Secondary outcomes (2)
asthma control
The patients' caregiver will be prompted to fill out an asthma control questionnaire every month. This questionnaire contains questions regarding renewal of prescription, control status and asthma attack.
Measured: 1 year
adherence to asthma treatment
Patients' adherence will be assessed by investigator through questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Yin, PhD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659225
- Sponsor's protocol ID
- SCMCIRB-YJ2022002
- Status last verified
- Nov 2022
- First submitted
- 13 Dec 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine System and Intelligent Monitoring System Construction of Pediatric Asthma Based on the Electronic Stethoscope
- ClinicalTrials.gov ID
- NCT05659225
- Acronym / sponsor ID
- SCMCIRB-YJ2022002
- Conditions
- Asthma
- Keywords
- Pediatric, Asthma Control, Electronic Stethoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Dec 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.
The purpose of this study is to retrofit the existing electronic stethoscope, improve the quality and efficiency of signal acquisition and the intelligent degree of information processing, decrease the manual action of electronic stethoscopes implemented by parents of asthma children, simplify the process of data transfer and the user's operational cost using signal processing, artificial intelligence technology, thus decreasing the feedback cycle between patients and clinicians. Eventually, we will construct an intelligent monitoring system based on the modified electronic stethoscope and explore the interactive remote management approaches on children's asthma at the same time, thus achieving revolutionized remote management of asthma.
Detailed description
(1) The design of hardware and software of the intelligent electronic stethoscope This project will optimize and develop the software and hardware equipment of electronic stethoscope according to the shortcomings of existing electronic stethoscopes.
- Get high-quality breath sound data through integrated ECG sensor and algorithms for denoising and the separation of heart sound and lung sound
- Develop algorithms and corresponding frameworks for visualization of breath sounds and mining of key information
- Develop algorithms for automatic recognition of abnormal breath sounds
- Transfer breath sound data efficiently and reliably based on the encoding-decoding architecture
- Optimize the breath sound data transmission process
- Construct the remote diagnosis and treatment methods and monitoring system for childhood asthma preliminary (2) The effect of telemedicine system and intelligent monitoring system based on intelligent stethoscope on children with asthma Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as baseline medical condition will be collected by the investigators. The subject will be randomly assigned to the control group and the electronic stethoscope group. The patient's caregiver who was assigned to the electronic stethoscope group will be instructed to install the electronic stethoscope developed by our team and its accessories, then they will be trained by investigators on how to use the electronic stethoscope.
During the study, patients will receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". If patients develop upper respiratory tract symptoms without fever, the investigator will give corresponding guidance to the control group and the electronic stethoscope group. If fever develops, it is recommended that patients directly go to the emergency department.
All patients' caregiver will be prompted to finish the test for respiratory and asthma control in kids (TRACK) every month. Patient's caregiver assigned to the electronic stethoscope group will also need to complete the collection, data upload and sharing of patient's breath sounds at least once a month to confirm that the electronic stethoscope is worked correctly.
After enrollment, patients will be requested to visit Shanghai Children's Medical Center at month 3, 6, 9, 12. During each onsite visit, subjects will receive lung function (≥4 years) and FENO tests and fill out the questionnaire regarding the number of asthma-related outpatient emergency department visits, asthma-related hospitalizations, SABA and systemic glucocorticoid use, missed work and school misses, and asthma-related medical expenses in the past 3 months. At 6- and 12-month's visit, pediatric asthma caregiver's quality of Life questionnaire (PACQLQ) needs to be completed at the same time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electronic stethoscope group | Other | Device: Electronic Stethoscope, Other: Standard treatment according to GINA(2019)During the study, subjects who diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" will be assigned to the control group and the electronic stethoscope group, and receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". The patient's caregiver will be instructed to use an electronic stethoscope to coordinate treatment and complete follow-up. |
| control group | Other | Other: Standard treatment according to GINA(2019)During the study, subjects who diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" will be assigned to the control group and the electronic stethoscope group, and receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosed as asthma according to "Guideline for the diagnosis and optimal management of asthma in children" in the respiratory clinic of Shanghai Children's Medical Center from January 2023 to January 2025
- Out-patient, female or male, 3 years old≤ age < 6 years old
- long-term maintenance therapy with inhaled glucocorticoids or concomitant leukotriene receptor antagonists
- Equipped with a household atomizer or spacer, it can afford the inhalation therapy of short-acting β2 receptor agonists (SABA) at home
- The subjects or subjects' caregiver must have a smart phone with Android or Harmony system at their disposal
Key exclusion criteria (3 listed)
- Acute exacerbation of asthma 30 days before enrollment (receive short-term prednisone treatment, emergency department visit or hospitalization due to acute asthma attacks)
- Other chronic lung diseases, cardiovascular diseases, blood system diseases, immunodeficiency diseases, neurological diseases, genetic or chromosomal abnormalities and other underlying diseases
- Patients or their caregivers can't complete the collection of breath sound
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 |
|---|---|---|
| Electronic StethoscopeAlso: study-specified asthma device programSubjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. The patient's caregiver who was assigned to the electronic stethoscope group will be instructed to install the electronic stethoscope developed by our team and its accessories, then they will be trained by investigators on how to use the electronic stethoscope. | Device | electronic stethoscope group |
| Standard treatment according to GINA(2019)Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. The patient's caregiver who was assigned to the control group will receieve standard treatment according to GINA(2019). | Other | control group, electronic stethoscope group |
Primary outcome
visits of asthma-related unplanned emergency department
Time frame: 1 year
Subjects will fill out a questionnaire to provide the number of unscheduled emergency department visits related to asthma (except for routine asthma follow-up visits every 3 months).
2 secondary outcomes
asthma control
Time frame: 1 year
adherence to asthma treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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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.
Yong Yin, PhD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Stethoscope and Standard treatment according to GINA(2019) in people with Asthma, run by Shanghai Children's Medical Center 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 6 inclusion and 3 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 3 Feb 2023. 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 Yong Yin, PhD (8618930830705, yinyong9999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visits of asthma-related unplanned emergency department (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2023.