Status:
RECRUITING
Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
Lead Sponsor:
Rhode Island Hospital
Collaborating Sponsors:
Brown University
University of Mississippi Medical Center
Conditions:
Asthma in Children
Sleep Hygiene
Eligibility:
All Genders
7-11 years
Phase:
NA
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 bal...
Detailed Description
Urban children with asthma are at high risk for short sleep, due to an environment that jeopardizes sleep and asthma management. Further, this group suffers from altered immune balance, a key biologic...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT05420766
Start Date
May 15 2022
End Date
July 31 2026
Last Update
September 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903