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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT05420766
Eligibility Criteria:
Inclusion:
* Children 7-11 years old
* Has physician-diagnosed asthma, per parent and pediatrician report
* Meets criteria for current persistent asthma with a current prescription for an asthma controller medicine
* Obtains 9.0-11.0 h of sleep per 24 h day in the past month
* Has a positive allergy skin test performed at the clinic visit
* Resides and attend school in one of the targeted urban areas (Rhode Island: East Providence, North Providence, Providence, Warwick, Cranston, Woonsocket, Central Falls, Pawtucket, Lincoln, Johnston. Massachusetts: Attleboro, North Attleboro, Fall River.
* Has a primary caregiver who speaks English
Exclusion:
* No asthma diagnosis
* No use of asthma controller medication
* Severe persistent asthma that is poorly controlled
* Diagnosis of additional pulmonary disease or medical condition or immune deficiency disorders
* Use of systemic steroids \<30 days of screening
* Asthma-related emergency department visit and/or asthma-related hospitalization in past 90 days
* Marked developmental delay, psychiatric conditions, academic/behavioral problems, learning disabilities
* Tanner stage 3-5 of pubertal development
* Diagnosed ADHD; Use of stimulants to treat ADHD
* An Apnea-Hypoxia Index \>5 (indicator of sleep disordered breathing)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
11 Years
Study:
NCT05420766
Study Brief:
Protocol Section:
NCT05420766