Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT05608668
Eligibility Criteria:
Inclusion Criteria:
* Documented informed consent from legal guardian and assent from participant as appropriate.
* Children 8 to 17 years of age with obesity (BMI ≥ 95th percentile for age and sex) and mild asthma.
* Participants (or parent/guardian) must have access to the internet and an approved smart device/computer.
* Child must have a designated caregiver who expresses a commitment to encourage the participant to complete the study procedures.
* Participant and legal guardian must speak and read English.
* Child is currently taking prescription medicine for asthma (Any type of albuterol or inhaled steroid)
Exclusion Criteria:
* Prior intubation for asthma
* Current self-reported pregnancy or planning to become pregnant.
* Have an FEV1 \< 50% of predicted at screening
* History of lung surgery in the past two years,
* History of pulmonary embolism in the past two years,
* Any history of recurrent spontaneous pneumothorax, or pneumothorax in the past 12 months
* Current undiagnosed chest pain,
* History of inner ear surgery in the past 12 months,
* Undiagnosed syncopal episodes in the past two years,
* Progressive neurological or neuromuscular disorders or need for chronic O2 therapy.
* Inability to complete baseline measurements satisfactorily according to the research coordinator's or PI's judgment.
* Any condition in the opinion of the PI that would not allow safe conduct of study procedures (including IMR, MIP testing or step-test), such as a physical disability, recent musculoskeletal injury or illness, current and ongoing evaluation for undiagnosed cardiopulmonary or neurologic symptoms
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT05608668
Study Brief:
Protocol Section:
NCT05608668