Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
Part of paid clinical trials in Providence, Rhode Island.
- Sponsor
- Rhode Island Hospital
- Study ID
- NCT05420766
- Status
- Recruiting
Conditions
- Asthma in Children
- Sleep Hygiene
- Sleep, Inadequate
Eligibility Criteria
- Sex
- ALL
- Age
- 7 Years - 11 Years
- Healthy Volunteers
- Not accepted
Interventions
- Shortened Sleep — BEHAVIORALIn this experimental condition, children go to bed 90 minutes later than their typical bedtime during Week 2 of the 4-week protocol.
- Stabilized sleep — BEHAVIORALIn this control condition, children go to bed at their usual time throughout the 4-week protocol.
Study Details
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.
Key Dates
- Start date
- May 15, 2022
- Status verified
- Sep 2025
- Primary completion
- Jul 1, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 204 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Shortened SleepIn this 4-week sleep protocol, children in this experimental condition follow a Stabilized Sleep schedule (i.e., their usual bed time) during weeks 1, 3 and 4. During week 2, they follow a Shortened Sleep schedule, during which they go to bed 90 later than is typical.
- Active Comparator: Usual Sleep ScheduleIn this control arm of the 4-week sleep protocol, children follow the Stabilized Sleep schedule for all 4 weeks.
Primary Outcome Measure
10mL of heparinized blood [ Time Frame: Changes in immune function across Days 7, 11, 14, 21 and 28 of the 4-week sleep protocol ]
Central Contacts
- Daphne Koinis-Mitchell, PhD401-793-8632
- Sheryl J Kopel, MSc401 444-7217
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02903 |
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