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Leo Study Unstable Asthma

Primary Purpose

Asthma in Children

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leo device monitoring
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma in Children

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm - Leo Device Monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

Airway resistance through oscillometry test
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.
Asthma Flare-up diary
Self-reported asthma flare-up diary score will be measured daily during the remote (at home) period in between visits.
CASI questionnaire
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

Secondary Outcome Measures

Inhaler usage
Propeller sensor will include measures of time stamped data of inhaler usage (controller and rescue inhalers)
Tidal breathing from PNT device
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.

Full Information

First Posted
March 14, 2022
Last Updated
September 23, 2022
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT05308277
Brief Title
Leo Study Unstable Asthma
Official Title
Engineering Validation of Leo Device to Assess Clinical Control of Children Recovering From Acute Asthma Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Engineering validation of a lung function monitoring device
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm - Leo Device Monitoring
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Leo device monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Airway resistance through oscillometry test
Description
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.
Time Frame
Baseline visit and 7 days post hospital/ED discharge
Title
Asthma Flare-up diary
Description
Self-reported asthma flare-up diary score will be measured daily during the remote (at home) period in between visits.
Time Frame
Follow-up for 7 days post hospital/ED discharge
Title
CASI questionnaire
Description
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
Time Frame
Baseline visit and 7 days post hospital/ED discharge
Secondary Outcome Measure Information:
Title
Inhaler usage
Description
Propeller sensor will include measures of time stamped data of inhaler usage (controller and rescue inhalers)
Time Frame
Follow-up for 7 days post hospital/ED discharge
Title
Tidal breathing from PNT device
Description
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.
Time Frame
7 days post hospital/ED discharge
Other Pre-specified Outcome Measures:
Title
Frequency and severity of localized skin reaction including redness and irritation / itchiness / discomfort.
Time Frame
7 days post hospital/ED discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faizan Javed, PhD
Phone
+61 413624856
Email
faizan.javed@resmed.com.au
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juana Cerna, MS
Phone
720-777-8384

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared through planned publications after de-identified analysis.

Learn more about this trial

Leo Study Unstable Asthma

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