Asthma in ChildrenAIMSNCT05420766
Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
A study testing Shortened Sleep and Stabilized sleep in people with Asthma in Children and Sleep Hygiene, run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Asthma in Children, Sleep Hygiene, Sleep, Inadequate
- What is being tested?
- Shortened Sleep and Stabilized sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Asthma in Children, Sleep Hygiene, Sleep, Inadequate
- Being tested
- Shortened Sleep, Stabilized sleep
- Keywords
- Sleep Hygiene, Children with asthma, Immune function in children
- Medical subject headings
- Sleep Hygiene, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortened SleepBehavioural
In this experimental condition, children go to bed 90 minutes later than their typical bedtime during Week 2 of the 4-week protocol.
Stabilized sleepBehavioural
In this control condition, children go to bed at their usual time throughout the 4-week protocol.
| Study group | Role | What they receive |
|---|---|---|
| Shortened Sleep | Experimental | 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. Receives: Behavioral: Shortened Sleep |
| Usual Sleep Schedule | Active comparator | In this control arm of the 4-week sleep protocol, children follow the Stabilized Sleep schedule for all 4 weeks. Receives: Behavioral: Stabilized sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Asthma-related lung function
Measured: Lung function over the 4-week sleep protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start15 May 2022
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, University of Mississippi Medical Center
- Responsible party
- Sponsor
- Investigators
- Daphne Koinis-Mitchell, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420766
- Sponsor's protocol ID
- R01HL156277
- Acronym
- AIMS
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
- ClinicalTrials.gov ID
- NCT05420766
- Acronym / sponsor ID
- AIMS / R01HL156277
- Conditions
- Asthma in Children, Sleep Hygiene, Sleep, Inadequate
- Keywords
- Sleep Hygiene, Children with asthma, Immune function in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Brown University, University of Mississippi Medical Center
- Study start
- 15 May 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shortened Sleep | Experimental | Behavioral: 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. |
| Usual Sleep Schedule | Active comparator | Behavioral: Stabilized sleepIn this control arm of the 4-week sleep protocol, children follow the Stabilized Sleep schedule for all 4 weeks. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shortened SleepIn this experimental condition, children go to bed 90 minutes later than their typical bedtime during Week 2 of the 4-week protocol. | Behavioural | Shortened Sleep |
| Stabilized sleepIn this control condition, children go to bed at their usual time throughout the 4-week protocol. | Behavioural | Usual Sleep Schedule |
Primary outcome
10mL of heparinized blood
Time frame: Changes in immune function across Days 7, 11, 14, 21 and 28 of the 4-week sleep protocol
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
1 secondary outcome
Forced Expiratory Flow in 1 second (FEV1) % predicted
Time frame: Lung function over the 4-week sleep protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphne Koinis-Mitchell, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shortened Sleep and Stabilized sleep in people with Asthma in Children and Sleep Hygiene, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.