- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05308277
Leo Study Unstable Asthma
Engineering Validation of Leo Device to Assess Clinical Control of Children Recovering From Acute Asthma Exacerbation
This is a prospective, observational study to investigate the agreement of the Leo device signal derivation with gold standard asthmatic testing in recently exacerbated asthmatic children.
This study is designed for engineering validation of a wireless, wearable device (Leo) for assessing clinical control of children recovering from acute respiratory event such as asthma attack. The Leo device will monitor chest impedance, ECG and body position to calculate parameters such as respiration rate, heart rate, lung volume, tidal breathing flow and volume curves, and body position. These parameters will then be used to train and algorithm to assess clinical control of asthma.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Faizan Javed, PhD
- Telefonnummer: +61 413624856
- E-mail: faizan.javed@resmed.com.au
Studiesteder
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- Children's Hospital Colorado
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Kontakt:
- Juana Cerna, MS
- Telefonnummer: 720-777-8384
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Children aged ≥2 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
- Children who are currently hospitalized with acute exacerbation of asthma
- Child's caregiver is able to communicate using SMS
- Child has an asthma inhaler
Exclusion Criteria:
- Children with complex medical conditions which may hinder their ability to complete protocol assessments
- 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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Single Arm - Leo Device Monitoring
Child's respiratory impedance will be continuously recorded using the Leo device during hospital/ED stay after consent and enrollment, and then during 7 days at home after discharge.
The Leo device provides no intervention, and will only monitoring chest impedance for the worn period.
Oscillometry and spirometry testing and flow volume assessment using PNT will be performed during study visits with Leo device attached.
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After consent and enrollment, the child's respiratory impedance will be continuously recorded using the Leo device throughout the day and night during the entire hospital stay or ED visit.
The device may be taken off for up to 1 hour per day (i.e., break during bath / shower time).
The device will be applied to the skin overlying the mid-sternum area on the chest wall after cleaning of the skin with an alcohol swab after consent has been obtained.
The device will be changed every 72 hours or earlier, by the participant's guardian, depending on signs of defect in the signal quality or battery exhaustion, based on daily check of the signal by the research team.
Remote monitoring of the child's chest impedance will continue using the Leo device after discharge from hospital/ED for 7 days.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Airway resistance through oscillometry test
Tidsramme: Baseline visit and 7 days post hospital/ED discharge
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Asthma severity measures will be determined through oscillometry test at baseline and follow-up visit.
Leo measurements will be assessed for agreement with oscillometry measures.
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Baseline visit and 7 days post hospital/ED discharge
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Asthma Flare-up diary
Tidsramme: Follow-up for 7 days post hospital/ED discharge
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Self-reported asthma flare-up diary score will be measured daily during the remote (at home) period in between visits.
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Follow-up for 7 days post hospital/ED discharge
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CASI questionnaire
Tidsramme: Baseline visit and 7 days post hospital/ED discharge
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Questionnaire will be used to determine asthma severity during baseline and follow-up visit.
CASI scores include five domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations.
Range is from 0 -17, with a higher score indicating worse asthma severity
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Baseline visit and 7 days post hospital/ED discharge
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Inhaler usage
Tidsramme: Follow-up for 7 days post hospital/ED discharge
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Propeller sensor will include measures of time stamped data of inhaler usage (controller and rescue inhalers)
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Follow-up for 7 days post hospital/ED discharge
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Tidal breathing from PNT device
Tidsramme: 7 days post hospital/ED discharge
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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 agreement.
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7 days post hospital/ED discharge
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Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Frequency and severity of localized skin reaction including redness and irritation / itchiness / discomfort.
Tidsramme: 7 days post hospital/ED discharge
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7 days post hospital/ED discharge
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RC-21-07-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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