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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Shortened Sleep, Stabilized Sleep for asthma?

The research suggests that sleep quality is linked to asthma control, with poor sleep associated with worse asthma symptoms. However, disrupting sleep does not seem to improve asthma symptoms, indicating that the treatment of shortened or stabilized sleep may not be effective for asthma. ^{1 2 3 4 5}

Is it safe to change sleep patterns for asthma treatment?

Research shows that disrupting sleep does not improve asthma symptoms and may lead to sleep disturbances like early morning awakening and daytime sleepiness. However, there is no specific evidence suggesting that changing sleep patterns is unsafe for humans. ^{1 3 6 7 8}

How does sleep duration treatment differ from other asthma treatments?

This treatment focuses on adjusting sleep duration to manage asthma symptoms, which is different from traditional asthma treatments that typically involve medications like inhalers. It explores the relationship between sleep patterns and asthma control, offering a novel approach by potentially improving asthma symptoms through better sleep management. ^{1 2 3 8 9}

Research Team

Daphne Koinis-Mitchell, PhD

Principal Investigator

Rhode Island Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does sleep cause nocturnal asthma? [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Association between sleep duration and asthma in different weight statuses (CHNS 2009-2015). [2021]

3. England pubmed.ncbi.nlm.nih.gov

Assessing sleep quality and daytime wakefulness in asthma using wrist actigraphy. [2008]

4. Thailand pubmed.ncbi.nlm.nih.gov

Sleep disturbances and asthma control: a real life study. [2016]

5. Spain pubmed.ncbi.nlm.nih.gov

Self-perceived Sleep Quality and Quantity in Adults With Asthma: Findings From the CosteAsma Study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Experimental methods to study sleep disruption and immune balance in urban children with asthma. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Sleep disturbances in patients with asthma. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Neuropsychological outcomes of nocturnal asthma. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep disturbances in clinically stable young asthmatic adults. [2015]