Asthma in ChildrenNCT04360213
Advanced Multimodal Wireless Vital Signs Monitoring for Patients With Asthma and Anaphylaxis
An observational study of Asthma in Children and Allergy, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of this study is to assess the function and reliability of a non-invasive, skin-like electronic sensor. We hypothesize that this skin sensor will address an unmet need to wirelessly, noninvasively, and rapidly assess critical vital signs and other measures essential to healthcare monitoring for… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Asthma in Children, Allergy
- What is being tested?
- Advanced multimodal wireless vital signs monitor
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 2 Sep 2022
- 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 1 year to 17 years
- All sexes
- Child
Study population: Children scheduled to come to the hospital or admitted into Emergency Department for allergy testing, anaphylaxis or asthma exacerbations.
Who may be able to join
- Patients ages 1 to 17 years old
- Patients scheduled to do an oral food challenge or managed in the ED or admitted to the hospital for asthma exacerbation.
- For exploratory analyses of breath sounds, patients in the ED with signs and symptoms of lower respiratory tract infection (e.g., bronchiolitis, pneumonitis, pneumonia).
Who cannot join
- 1. Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed (including wounds, blistering, cracked or peeling skin, burns or skin that is bandaged/covered)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2991
About this study
The primary objective of this study is to assess the function and reliability of a non-invasive, skin-like electronic sensor.
We hypothesize that this skin sensor will address an unmet need to wirelessly, noninvasively, and rapidly assess critical vital signs and other measures essential to healthcare monitoring for patients with asthma and anaphylaxis.
Read the detailed description
In clinical and home settings sensors to monitor vital parameters (including heart rate, ECG, respiratory rate, temperature, and pulse oximetry) require the application and removal of multiple, often bulky apparatuses. Furthermore, each requires constant, wired attachment to a power supply and operators, which can limit visibility and impair the ability to move a patient without interference. Serial measurements require significant time, as several devices with separate leads are applied and removed to obtain measurements. Due to the varying and often large measurement heads of different devices, readings may not be obtained at exactly the same skin location, which impairs comparability of serial measurements. Additionally, the process of measurement can disturb the skin area being measured.
Asthma and anaphylaxis are common entities in children. During exacerbations, frequent monitoring of the vital parameters described is necessary to guide medical decision-making. Asthma exacerbations are associated with mild to severe symptoms that include cough, wheeze, tachypnea, retractions, labored breathing and respiratory fatigue. Food allergy reactions are potentially severe with life-threatening symptoms of anaphylactic shock that include, choking, respiratory distress and loss of consciousness. In the most severe cases reactions can be fatal or require emergency and intensive care treatment in the hospital. Convenient, easy to use, vital signs monitors are especially important in pediatric populations as children have less ability to self-monitor or describe their physical symptoms of life-threatening anaphylaxis or asthma exacerbation.
The wearable sensors offer a new, non-invasive and easy to use way to monitor vital signs of patients with asthma and anaphylaxis. Our previous experience testing our wearable vital sign sensors in multiple pediatric and neonatal studies since 2016, have shown a strong correlation to existing standard of care monitor data outputs. Additionally, the sensors have received positive feedback from patients and physicians, on their comfort, ease of use, and application.
- Conditions
- Asthma in Children, Allergy
- Being tested
- Advanced multimodal wireless vital signs monitor
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced multimodal wireless vital signs monitorDevice
Investigators have developed a lightweight, stretchable 'skin-like' membranes, called skin sensors. These small, paper-thin monitors were created by matching the mechanical properties of skin, and can be applied to the skin's surface without skin disturbance. Each patch is encapsulated using medical grade materials and applied using single use medical grade skin adhesive integrated with eco-fused fabric (moisture wicking layer between adhesives). The adhesive may be changed between uses, and the device itself can be cleaned with Super Sani-Cloth®, commonly used in the hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Children with Asthma | 1. Patients ages 1 to 17 years old
2. Patients in the Emergency Department or admitted to the hospital for asthma exacerbation. Receives: Device: Advanced multimodal wireless vital signs monitor | |
| Children with allergy | 1. Patients ages 1 to 17 years old
2. Patients scheduled to do an oral food challenge Receives: Device: Advanced multimodal wireless vital signs monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent agreement with pilot sensor and current standard
Measured: 2 years
Secondary outcomes (2)
Capture of patient feedback examining opinions on use of wearable sensors compared to standard of care devices.(Allergy patients)
Use of Standardized survey instrument: IRB 2020-3403 Allergy Survey 2.21.20 Collects data on users perceived value of wireless monitoring, comfort, application and ease of use.
Measured: 2 years
Capture of patient feedback examining opinions on use of wearable sensors compared to standard of care devices.(Asthma patients)
Use of Standardized survey instrument: IRB 2020-3403 Asthma Survey 2.21.20 Collects data on users perceived value of wireless monitoring, comfort, application and ease of use.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jun 2021
- Primary completion16 Aug 2021
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360213
- Sponsor's protocol ID
- 2020-3403
- Status last verified
- Oct 2023
- First submitted
- 15 Apr 2020
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Multimodal Wireless Vital Signs Monitoring for Patients With Asthma and Anaphylaxis
- ClinicalTrials.gov ID
- NCT04360213
- Acronym / sponsor ID
- 2020-3403
- Conditions
- Asthma in Children, Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 24 Apr 2020 (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 primary objective of this study is to assess the function and reliability of a non-invasive, skin-like electronic sensor.
We hypothesize that this skin sensor will address an unmet need to wirelessly, noninvasively, and rapidly assess critical vital signs and other measures essential to healthcare monitoring for patients with asthma and anaphylaxis.
Detailed description
In clinical and home settings sensors to monitor vital parameters (including heart rate, ECG, respiratory rate, temperature, and pulse oximetry) require the application and removal of multiple, often bulky apparatuses. Furthermore, each requires constant, wired attachment to a power supply and operators, which can limit visibility and impair the ability to move a patient without interference. Serial measurements require significant time, as several devices with separate leads are applied and removed to obtain measurements. Due to the varying and often large measurement heads of different devices, readings may not be obtained at exactly the same skin location, which impairs comparability of serial measurements. Additionally, the process of measurement can disturb the skin area being measured.
Asthma and anaphylaxis are common entities in children. During exacerbations, frequent monitoring of the vital parameters described is necessary to guide medical decision-making. Asthma exacerbations are associated with mild to severe symptoms that include cough, wheeze, tachypnea, retractions, labored breathing and respiratory fatigue. Food allergy reactions are potentially severe with life-threatening symptoms of anaphylactic shock that include, choking, respiratory distress and loss of consciousness. In the most severe cases reactions can be fatal or require emergency and intensive care treatment in the hospital. Convenient, easy to use, vital signs monitors are especially important in pediatric populations as children have less ability to self-monitor or describe their physical symptoms of life-threatening anaphylaxis or asthma exacerbation.
The wearable sensors offer a new, non-invasive and easy to use way to monitor vital signs of patients with asthma and anaphylaxis. Our previous experience testing our wearable vital sign sensors in multiple pediatric and neonatal studies since 2016, have shown a strong correlation to existing standard of care monitor data outputs. Additionally, the sensors have received positive feedback from patients and physicians, on their comfort, ease of use, and application.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Asthma | – | Device: Advanced multimodal wireless vital signs monitor1. Patients ages 1 to 17 years old 2. Patients in the Emergency Department or admitted to the hospital for asthma exacerbation. |
| Children with allergy | – | Device: Advanced multimodal wireless vital signs monitor1. Patients ages 1 to 17 years old 2. Patients scheduled to do an oral food challenge |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Children scheduled to come to the hospital or admitted into Emergency Department for allergy testing, anaphylaxis or asthma exacerbations.
Key inclusion criteria (3 listed)
- Patients ages 1 to 17 years old
- Patients scheduled to do an oral food challenge or managed in the ED or admitted to the hospital for asthma exacerbation.
- For exploratory analyses of breath sounds, patients in the ED with signs and symptoms of lower respiratory tract infection (e.g., bronchiolitis, pneumonitis, pneumonia).
Key exclusion criteria (1 listed)
- 1. Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed (including wounds, blistering, cracked or peeling skin, burns or skin that is bandaged/covered)
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 |
|---|---|---|
| Advanced multimodal wireless vital signs monitorInvestigators have developed a lightweight, stretchable 'skin-like' membranes, called skin sensors. These small, paper-thin monitors were created by matching the mechanical properties of skin, and can be applied to the skin's surface without skin disturbance. Each patch is encapsulated using medical grade materials and applied using single use medical grade skin adhesive integrated with eco-fused fabric (moisture wicking layer between adhesives). The adhesive may be changed between uses, and the device itself can be cleaned with Super Sani-Cloth®, commonly used in the hospital setting. | Device | Children with Asthma, Children with allergy |
Primary outcome
Percent agreement with pilot sensor and current standard
Time frame: 2 years
2 secondary outcomes
Capture of patient feedback examining opinions on use of wearable sensors compared to standard of care devices.(Allergy patients)
Time frame: 2 years
Capture of patient feedback examining opinions on use of wearable sensors compared to standard of care devices.(Asthma patients)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Allergy, run by Northwestern University at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 13 Oct 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent agreement with pilot sensor and current standard (time frame: 2 years). 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 13 Oct 2023.