An interventional study of Shortened Sleep and Stabilized sleep in Asthma in Children, Sleep Hygiene and Sleep, Inadequate, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Other
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.
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 biological process contributing to individual differences in asthma morbidity and sleep health. Allergic asthma is a chronic inflammatory disorder driven primarily by disturbed T helper 1 (Th1)/ 2 (Th2) cytokine balance marked by Th2 cytokine (IL-4, IL-5 and/or IL-13) predominance. Experimental findings in healthy adults show that shortened sleep increases inflammatory cytokine (e.g., IL-6) and certain Th2 cytokine levels and that recovery sleep following sleep restriction promotes a return to immune balance. Whether sleep duration plays a key role in immune function and associated asthma activity in urban children with asthma remains a scientific gap. The researchers use an experimental design that targets sleep duration, because (1) the urban environment and asthma symptoms interact to shorten sleep, (2) sleep duration is a modifiable behavior overlooked in clinical care of urban children with asthma, and (3) experimental data are critical to test a causal link for sleep duration as a mechanism underlying immune balance and asthma.
The research team will enroll urban children (N=204; ages 7-11 years) with persistent allergic asthma and adequate sleep duration (9-11 h) who will complete a 4-week within-subjects protocol that includes 3 scheduled experimental sleep conditions: (1) 1 week stabilized sleep (individualized; 9-11 h time in bed), (2) 1 week shortened sleep (1.5 h decrease in time in bed), and (3) 2 weeks recovery sleep (1.5 h increase in time in bed). Sleep duration (actigraphy) and lung function (home spirometry) will be monitored daily and assess immune biomarkers weekly and at the midpoint of shortened sleep. To control time-in-study effects, 1/3 of the sample will receive only the stabilized sleep schedule across the 4-week protocol. In this project, the researchers will study only urban children with allergic asthma who obtain sufficient sleep (9-11 h, within national guidelines). The shortened sleep protocol will model the sleep loss that urban children with asthma can experience due to asthma and/or urban context. Additionally, the recovery sleep protocol simulates a sleep optimization intervention following shortened sleep in a well-controlled approach.
The first aim of the study is to examine the effects of shortened sleep on immune balance [e.g., Th1 (Interferon-IFN gamma)/Th2 (Interleukin-IL-4, IL-5, IL-13)R and plasma IL-6 levels]. The second aim involves determining the effects of recovery sleep on immune balance. The third aim involves examining the extent to which changes in immune balance are associated with changes in asthma-related lung function (changes in FEV1) under conditions of shortened and recovery sleep. Results from this study ultimately will support the development feasible, ecologically valid, and clinically meaningful interventions to optimize sleep duration, immune balance, and asthma in this at-risk group.
126 studies on the registry are indexed under Sleep Hygiene; 32 are open to participants now.
This study's enrollment of 83 is above the median of 66 across 113 interventional studies indexed under Sleep Hygiene.
Browse Sleep Hygiene studies →Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In 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.
Behavioral: Shortened Sleep
In this control arm of the 4-week sleep protocol, children follow the Stabilized Sleep schedule for all 4 weeks.
Behavioral: Stabilized sleep
In this experimental condition, children go to bed 90 minutes later than their typical bedtime during Week 2 of the 4-week protocol.
In this control condition, children go to bed at their usual time throughout the 4-week protocol.
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 protocol
Forced Expiratory Flow in 1 second (FEV1) % predicted
Asthma-related lung function
Time frame: Lung function over the 4-week sleep protocol
Time in Bed actigraphy scores
Sleep Duration measured via actigraphy, to validate the prescribed sleep schedules
Time frame: Continuously throughout the 4-week sleep protocol
Plan to share: Yes — Following the NIH data sharing policy (2015), within one year of completion of the study and dissemination of primary study results, public-use analysis datasets will be made available to the public, along with the final version of the study protocol, data dictionaries and brief instructions. De-identification for the analysis data sets will follow published guidelines for "limited access data sets" funded by NHLBI (Geller et al., 2004).
Supporting information: Study protocol, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available within one year of completion of the study and dissemination of primary study results and will be available for 10 years following the completion of the study.
Access criteria: Once data become available, researchers requesting the data would follow the published "Project AIMS" data request procedures (available from the PI or designate). We will make data available to potential users only under an NIH-approved data sharing agreement that provides for 1) a commitment to using the dta only for research purposes and not to identify any individual participant in any way; 2) a commitment to securing the data using appropriate information security this is compliant with the most current federal guidelines that are outlined by our information security protocol; and 3) a commitment to destroying or returning the data after completion of analyses.
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Jul 2026, 50 months.
Of 75 non-industry interventional studies with no phase under Sleep Hygiene, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 50 months is above that.
Counting every sponsor, half of 79 studies reached it within 8 months; a quarter within 4 and three quarters within 18.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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