Sleep Duration for Asthma

(AIMS Trial)

Overseen By Sheryl J Kopel, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Must be taking: Asthma controllers

Must not be taking: Systemic steroids, Stimulants

Disqualifiers: Severe asthma, Pulmonary disease, ADHD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different sleep patterns affect children with allergic asthma in urban areas. Researchers examine the impact of shortened sleep on immune function and lung health compared to a regular sleep schedule. The trial includes two groups: one group follows a shortened sleep schedule for one week and a regular schedule for the rest, while the other group maintains their usual sleep schedule throughout. The study seeks children aged 7-11 with persistent asthma who take asthma medication and live in specific urban areas in Rhode Island or Massachusetts. As an unphased trial, this study provides a unique opportunity to understand how sleep affects asthma in children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to have a current prescription for an asthma controller medicine. It seems likely that you will need to continue your asthma medication during the trial.

What prior data suggests that this sleep protocol is safe for children with asthma?

Research shows that insufficient sleep can be risky for people with asthma. Studies have found that adults who sleep too little are more likely to experience asthma attacks and issues like a dry cough. Some even require overnight hospital visits. Lack of sleep might also make asthma harder to manage and lead to more flare-ups.

Although this research focuses on adults, it provides insight into how sleep affects asthma. This information is important when considering the safety of reduced sleep. While the effects on children remain unclear, understanding the impact on adults can be useful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how sleep duration can impact asthma management, a fresh perspective compared to typical treatments like inhalers and medications. The trial is unique because it investigates the effects of altering sleep patterns, specifically by shortening sleep, to see if it influences asthma symptoms. This approach could offer a non-pharmacological strategy for managing asthma, potentially reducing the need for medications and their side effects. Understanding the link between sleep and asthma might lead to new guidelines for improving quality of life for those with asthma.

What evidence suggests that this trial's sleep protocols could be effective for asthma?

This trial will compare the effects of different sleep schedules on asthma symptoms. Research has shown that insufficient sleep is linked to worse asthma symptoms. People who sleep less often report more asthma attacks and have a higher chance of having asthma. One study found that adults who don't get enough sleep are 1.5 times more likely to have an asthma attack compared to those who sleep normally. Another study suggested that insufficient sleep can increase the risk of asthma, especially if someone also has extra weight around their stomach. Overall, getting less sleep seems to make asthma harder to control, making it an important factor in managing the condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Daphne Koinis-Mitchell, PhD

Principal Investigator

Rhode Island Hospital

Are You a Good Fit for This Trial?

This trial is for urban children aged 7-10 with allergic asthma, who sleep 9-11 hours daily and are on asthma control medicine. They must have a positive allergy test, speak English at home, and live in certain urban areas. Kids can't join if they've had recent severe asthma issues, other lung or immune diseases, ADHD on stimulants, advanced puberty stages, used steroids recently or have significant developmental or learning problems.

Inclusion Criteria

I have ongoing asthma and am prescribed medication to control it.

My child is between 7 and 10 years old.

You have been getting 9 to 11 hours of sleep per day for the past month.

Exclusion Criteria

I have been to the ER or hospitalized for asthma in the last 3 months.

I have ADHD and am taking stimulants for it.

I am in the mid to late stages of puberty.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stabilized Sleep

Participants follow their usual bed time schedule for 1 week

1 week

Daily monitoring (virtual)

Shortened Sleep

Participants follow a shortened sleep schedule, going to bed 90 minutes later than usual

1 week

Daily monitoring (virtual)

Recovery Sleep

Participants follow a recovery sleep schedule, increasing time in bed by 1.5 hours

2 weeks

Daily monitoring (virtual)

Follow-up

Participants are monitored for changes in immune balance and lung function

4 weeks

Weekly assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Shortened Sleep
• Stabilized sleep

Trial Overview

The study looks at how different sleep patterns affect the immune system and lung function in kids with asthma. Researchers will change the children's sleep duration to see if it impacts their immune balance—a factor in both asthma severity and overall sleep quality.

How Is the Trial Designed?

Group I: Shortened Sleep Experimental Treatment 1 Intervention

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.

Group II: Usual Sleep Schedule Active Control 1 Intervention

In this control arm of the 4-week sleep protocol, children follow the Stabilized Sleep schedule for all 4 weeks.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Brown University

Collaborator

Trials

480

Recruited

724,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

In a study of asthma patients, 44% reported unsatisfactory asthma control, and those with better control experienced fewer sleep disturbances, indicating a clear link between asthma management and sleep quality.

Interestingly, even patients with total asthma control (11-20%) still reported sleep disturbances, suggesting that these issues may stem from other health problems, highlighting the need for comprehensive evaluations and possible sleep studies for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbances and asthma control: a real life study. Braido, F., Baiardini, I., Ghiglione, V., et al.[2016]

The study highlights that sleep disruption in urban children with persistent asthma can lead to an imbalance in immune function, specifically affecting Th1/Th2 cytokine profiles, which may worsen asthma control.

Using a structured sleep schedule and polysomnography, the research demonstrated that even short-term sleep interruptions can have significant negative effects on both immune balance and lung function, emphasizing the importance of sleep for managing asthma in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental methods to study sleep disruption and immune balance in urban children with asthma. Koinis-Mitchell, D., Marshall, GD., Kopel, SJ., et al.[2023]

Nocturnal asthma is linked to fatigue and cognitive performance issues, but current evidence shows that while symptoms improve with treatment, daytime performance does not significantly change.

Future studies should include children, as they may experience more severe daytime consequences from nocturnal asthma compared to adults, highlighting the need for targeted research in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological outcomes of nocturnal asthma. Bender, BG., Annett, RD.[2019]

In a study of 1,098 asthmatic adults, those with more severe asthma experienced significantly poorer sleep quality and quantity, indicating a strong link between asthma severity and sleep disturbances.

Improving control of nocturnal asthma symptoms could enhance sleep quality and reduce daytime sleepiness, suggesting that clinicians should routinely assess sleep issues in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-perceived Sleep Quality and Quantity in Adults With Asthma: Findings From the CosteAsma Study. Sanz de Burgoa, V., Rejas, J., Ojeda, P.[2016]

In a study of 30 young adults with stable bronchial asthma, 93% reported sleep disturbances, significantly higher than the 33% in a control group, indicating that asthma greatly impacts sleep quality.

Asthmatic patients experienced shorter sleep duration (427 minutes) and higher rates of daytime sleepiness and tiredness, which could impair their daytime performance and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbances in clinically stable young asthmatic adults. Vir, R., Bhagat, R., Shah, A.[2015]

The study of 10 individuals with mild to moderate asthma over 7 days revealed that poor asthma control is linked to worse sleep quality, including longer time to fall asleep and more frequent awakenings at night.

Forty percent of participants experienced clinically significant daytime sleepiness, which was associated with poor asthma control and limitations in daily activities, highlighting the importance of managing asthma for better overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing sleep quality and daytime wakefulness in asthma using wrist actigraphy. Krouse, HJ., Yarandi, H., McIntosh, J., et al.[2008]

In a study of 98 adult asthmatic patients, common sleep disturbances included early morning awakenings (51%), difficulty maintaining sleep (44%), and daytime sleepiness (44%), indicating that poor sleep quality is prevalent in this population.

The study found that as asthma control worsened, patients experienced more sleep issues, such as increased nocturnal wakefulness and breathing problems, highlighting the impact of asthma severity on sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbances in patients with asthma. Janson, C., Gislason, T., Boman, G., et al.[2019]

In a study involving 21 patients with nocturnal asthma, sleep interruption and exercise did not improve peak expiratory flow rate (PEFR) during the night, indicating that disrupting sleep is not an effective treatment for nocturnal asthma.

The research showed that while circadian rhythms affect PEFR, sleep itself does not cause nocturnal asthma, as some patients experienced PEFR drops while awake after sleep deprivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does sleep cause nocturnal asthma? Hetzel, MR., Clark, TJ.[2019]

In a study of 32,776 Chinese adults, both short (≤6 hours) and long (≥9 hours) sleep durations were linked to a higher prevalence of asthma compared to optimal sleep (7-8 hours), with adjusted odds ratios indicating significant risks.

Participants with central obesity showed the highest asthma prevalence among different sleep duration groups, suggesting that both sleep duration and weight status are important factors in asthma risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between sleep duration and asthma in different weight statuses (CHNS 2009-2015). Hu, Z., Song, X., Hu, K., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9159162/

The Effect of Short Sleep Duration on the Development of ...

The results showed that short sleep duration seems to significantly increase the risk of asthma with central obesity but has no significant ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2213219822013241

Self-Reported Insufficient Sleep Is Associated With Clinical ...

In recent years, a few studies found that patients with short sleep duration may have worse patient-reported asthma outcomes, including a high risk for asthma ...

3.

bmcgeriatr.biomedcentral.com

bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03587-2

The effect and relative importance of sleep disorders for all ...

Previous studies demonstrated that short sleep duration is associated with a significantly higher prevalence of asthma [11] and asthmatic ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7830707/

Associations of sleep duration with patient-reported ...

The current study found adults with asthma and short sleep duration are 1.5 times as likely to have an asthma attack as compared to those ...

5.

jaci-inpractice.org

jaci-inpractice.org/article/S2213-2198(23)00124-1/fulltext

Sleep Duration, Inflammation, and Asthma Control

Asthma patients have increased sleep latency and reduced sleep quality and efficiency; each of which worsen with increased asthma severity.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1081120620303161

Associations of sleep duration with patient-reported ...

Of the 1389 adults with asthma, 26% reported short sleep duration, 66% reported normal sleep duration, and 8% reported long sleep duration. Those with short ...

7.

acaai.org

acaai.org/news/too-little-sleep-can-mean-more-asthma-attacks-in-adults/

Too little sleep can mean more asthma attacks in adults

Short sleepers, as compared to normal sleepers, had a greater likelihood of an asthma attack, dry cough, and an overnight hospitalization ...