Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-11
SponsorRhode Island Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: Shortened SleepExperimental treatment 1 intervention
Group B: Usual Sleep ScheduleActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
10mL of heparinized blood
Changes in the immune biomarker profile related to lung function and asthma morbidity: CD4+IFNy+ Th1 cells; CD4+IL4+, CD4+IL5+, CD4+IL13+ Th2 cells; plasma IL-6
Time frame
Changes in immune function across Days 7, 11, 14, 21 and 28 of the 4-week sleep protocolSecondary outcomes
1
Forced Expiratory Flow in 1 second (FEV1) % predicted
Asthma-related lung function
Time frame
Lung function over the 4-week sleep protocolOther outcomes
1
Time in Bed actigraphy scores
Sleep Duration measured via actigraphy, to validate the prescribed sleep schedules
Time frame
Continuously throughout the 4-week sleep protocolSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rhode Island Hospital
Lead sponsor
Brown University
Collaborator
University of Mississippi Medical Center
Collaborator
Source ClinicalTrials.gov