Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-01 @ 11:25 PM
Study NCT ID:
NCT05420766
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
Sponsor:
Rhode Island Hospital
Organization:
Study Overview
Official Title:
Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIMS
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.
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 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: