NCT05420766 Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
| NCT ID | NCT05420766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rhode Island Hospital |
| Condition | Asthma in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2022-05-15 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2022-05-15 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Daphne Koinis-Mitchell, PhD
PRINCIPAL INVESTIGATOR
Rhode Island Hospital
Frequently Asked Questions
Who can join the NCT05420766 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 11 Years, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05420766 currently recruiting?
Yes, NCT05420766 is actively recruiting participants. Contact the research team at dkoinismitchell@lifespan.org for enrollment information.
Where is the NCT05420766 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT05420766 clinical trial?
NCT05420766 is sponsored by Rhode Island Hospital. The principal investigator is Daphne Koinis-Mitchell, PhD at Rhode Island Hospital. The trial plans to enroll 204 participants.
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