Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
AIMS
1 other identifier
interventional
204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2022
CompletedFirst Submitted
Initial submission to the registry
June 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
September 22, 2025
September 1, 2025
4.1 years
June 2, 2022
September 19, 2025
Conditions
Keywords
Outcome Measures
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
Changes in immune function across Days 7, 11, 14, 21 and 28 of the 4-week sleep protocol
Secondary Outcomes (1)
Forced Expiratory Flow in 1 second (FEV1) % predicted
Lung function over the 4-week sleep protocol
Other Outcomes (1)
Time in Bed actigraphy scores
Continuously throughout the 4-week sleep protocol
Study Arms (2)
Shortened Sleep
EXPERIMENTALIn 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.
Usual Sleep Schedule
ACTIVE COMPARATORIn this control arm of the 4-week sleep protocol, children follow the Stabilized Sleep schedule for all 4 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rhode Island Hospitallead
- Brown Universitycollaborator
- University of Mississippi Medical Centercollaborator
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daphne Koinis-Mitchell, PhD
Rhode Island Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2022
First Posted
June 15, 2022
Study Start
May 15, 2022
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, 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.
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).