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Advanced Multimodal Wireless Vital Signs Monitoring for Patients With Asthma and Anaphylaxis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Year - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients ages 1 to 17 years old 2. Patients scheduled to do an oral food challenge or managed in the ED or admitted to the hospital for asthma exacerbation. 3. For exploratory analyses of breath sounds, patients in the ED with signs and symptoms of lower respiratory tract infection (e.g., bronchiolitis, pneumonitis, pneumonia). Exclusion Criteria 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04360213
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northwestern University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Asthma in Children, Allergy
Additional Details

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.

Arms & Interventions

Arms

: Children with Asthma

Patients ages 1 to 17 years old Patients in the Emergency Department or admitted to the hospital for asthma exacerbation.

: Children with allergy

Patients ages 1 to 17 years old Patients scheduled to do an oral food challenge

Interventions

Device: - Advanced multimodal wireless vital signs monitor

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Knute Martell

DermSensors@northwestern.edu

312-503-5944

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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