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- Klinische proef NCT04873193
Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
Safety and Feasibility of Utilizing a Novel Wearable Device (Leo) for Assessing Respiratory Function in Children With Respiratory Condition - a Pilot Early Phase Clinical Study
This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma).
There is no product currently on the market that is comparable to this novel Leo device
The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma.
Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.
There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Children's Colorado Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Children aged ≥3 years old and ≤18 years old at time of consent
- Children with a legal guardian able to sign consent for study participation
- Children and caregivers able to read and understand English or Spanish
- Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
- Children who are able to follow instructions and complete oscillometry and tidal breathing tasks
Exclusion Criteria:
- - Children <3 and >18 years of age
- Adults (age ≥ 18 years)
- Children with complex medical conditions which may hinder their ability to complete protocol assessments
- Children who do not have a legal guardian to sign informed consent form
- Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
- Child is determined not eligible by the assessment of the PI
- Fever within the 4 weeks prior to enrollment
- Children with any implanted medical devices, E.g. cardiac pacemaker
- Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device
- Children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Toestel Haalbaarheid
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: Oscillometry + Pneumotach Procedure with Leo Device measurements
All patients will undergo oscillometry procedure, followed by pneumotach procedure to measure tidal volume in different sitting positions. The Leo device will be worn throughout both procedures to measure the chest electrical impedance and compare against pneumotach measurements. Oscillometry and pneumotach are part of standard of care. |
Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Slow vital capacity from Leo device
Tijdsspanne: Baseline
|
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device.
The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Slow vital capacity from PNT device
Tijdsspanne: Baseline
|
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device.
The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Tidal breathing from Leo device
Tijdsspanne: Baseline
|
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device.
The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Tidal breathing from PNT device
Tijdsspanne: Baseline
|
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device.
The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Usability
Tijdsspanne: Baseline
|
Clinician, patient and caregiver usability feedback on the use of the Leo device through an IRB approved participant questionnaire.
|
Baseline
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Andrew Liu, Children's Hospital Colorado
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- OTH-21-02-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD delen Ondersteunend informatietype
- Leerprotocool
- Statistisch Analyse Plan (SAP)
- Formulier voor geïnformeerde toestemming (ICF)
- Klinisch onderzoeksrapport (CSR)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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