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NCT05945355 · ClinicalTrials.gov registry record · NA
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
A NA study of Obesity and Pediatric Obesity, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 76
- Enrollment target
- 2
- Study locations
NCT05945355 is a NA study of Obesity and Pediatric Obesity that is actively recruiting participants, run by Duke University. The registered enrollment target is 76 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05945355, a NA study of Obesity and Pediatric Obesity, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status
Conditions Studied
Interventions
- DEVICE Pro2 - Low Dose - 40% of participant's MIP
- DEVICE Pro2 - High Dose - 75% of participant's MIP
- DEVICE Pro2 - SHAM - 15% of participant's MIP
Study Locations (2)
North Carolina
- Duke Health Center Creekstone - Durham
- Duke Healthy Lifestyles Clinic - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2027-10-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05945355
The ClinicalTrials.gov registry entry for NCT05945355 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (91% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Pro2 - Low Dose - 40% of participant's MIP is the first listed.
NCT05945355 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05945355 about?
NCT05945355 is a clinical study titled "Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)". This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway ...
What is the current status of trial NCT05945355?
This trial is currently recruiting. It is a NA study. The enrollment target is 76 participants. The study started on 2024-08-01. Estimated completion is 2027-10-30.
What conditions does trial NCT05945355 study?
This clinical trial studies the following conditions: Obesity, Pediatric Obesity, Asthma in Children, Pediatric Asthma.
What interventions are being tested in trial NCT05945355?
The interventions under investigation include: Pro2 - Low Dose - 40% of participant's MIP (DEVICE), Pro2 - High Dose - 75% of participant's MIP (DEVICE), Pro2 - SHAM - 15% of participant's MIP (DEVICE).
Who is sponsoring clinical trial NCT05945355?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05945355 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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