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Single Arm - Leo Device Monitoring for Childhood Asthma

N/A
Recruiting
Research Sponsored by ResMed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post hospital/ed discharge
Awards & highlights

Study Summary

This trial will recruit recently exacerbated asthmatic children (n=30) to validate the Leo device against gold standard testing for clinical control of asthma.

Eligible Conditions
  • Childhood Asthma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days post hospital/ed discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days post hospital/ed discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Airway resistance through oscillometry test
Asthma Flare-up diary
CASI questionnaire
Secondary outcome measures
Inhaler usage
Tidal breathing from PNT device
Other outcome measures
Anniversary Reaction

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm - Leo Device MonitoringExperimental Treatment1 Intervention
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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Who is running the clinical trial?

ResMedLead Sponsor
135 Previous Clinical Trials
43,776 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are enrolled in the trial at this time?

"Affirmative. The clinical trial registry indicates that this medical study is actively recruiting participants. This project, which was initially posted on April 27th 2022, needs to locate 30 patients from one clinic."

Answered by AI

Who would be an eligible participant for this experimental program?

"Candidates between the ages of 2 and 18, with a diagnosis of asthma in children, are eligible to participate in this study. Currently, 30 patients have been enrolled."

Answered by AI

Are there any vacancies in this investigation for potential participants?

"According to clinicaltrials.gov, this medical trial opened for recruitment on April 27th 2022 and was revised most recently on September 23rd of the same year."

Answered by AI

Is this research endeavor open to people of eighteen years and older?

"This medical study is searching for participants aged 2-18 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Leo Study Unstable Asthma
2022. "Leo Study Unstable Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05308277.
~10 spots leftby Apr 2025
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