NCT05420766 · Rhode Island Hospital
Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
(AIMS)
What this study is about
Urban children with asthma are at high risk for short sleep, due to an environment that jeopardizes both sleep and asthma management. Further, urban children with asthma suffer from altered immune balance, a key biological process contributing to individual differences in asthma morbidity and sleep health.
View original scientific description
Urban children with asthma are at high risk for short sleep, due to an environment that jeopardizes both sleep and asthma management. Further, urban children with asthma suffer from altered immune balance, a key biological process contributing to individual differences in asthma morbidity and sleep health. In the proposed research, the researchers will examine the effects of shortened and recovery sleep on immune balance and associated changes in lung function in urban children with allergic asthma through an experimental design.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
Where
- Providence, Rhode Island
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2025 · Source of record for eligibility and locations