Sleep Duration for Asthma
(AIMS Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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.
12345Is 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.
13678How 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.
12389Eligibility 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.
+4 more
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.
+7 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Shortened SleepExperimental Treatment1 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 ScheduleActive Control1 Intervention
In this control arm of the 4-week sleep protocol, children follow the Stabilized Sleep schedule for all 4 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rhode Island HospitalProvidence, RI
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Who Is Running the Clinical Trial?
Rhode Island HospitalLead Sponsor
Brown UniversityCollaborator
University of Mississippi Medical CenterCollaborator
University of Colorado, DenverCollaborator
References
Does sleep cause nocturnal asthma? [2019]The effects of sleep interruption and deprivation were studied in 21 patients with nocturnal asthma. Seven patients were awakened at 0200 on three consecutive night and exercised for 15 minutes. This produced no significant improvement in the overnight fall in peak expiratory flow rate (PEFR) compared with a control night of uninterrupted sleep. In a second study in five patients PEFR was measured at two-hourly intervals to estimate the time of onset of the nocturnal fall in PEFR. On three subsequent nights they were awakened and exercised one hour before this time. This also failed to prevent a fall in PEFR by 0600. Eleven patients, who had followed a similar protocol to the second study, were kept awake until after 0300 or later, and PEFR was observed hourly. Six of them (group A) sustained their usual fall in PEFR while awake, proving that sleep was not responsible for their nocturnal asthma. Five patients (group B) showed little fall in PEFR until they were allowed to sleep, when an appreciable fall was noted on waking at 0600. When sleep deprivation was repeated in two patients in group B, however, they sustained falls in PEFR while still awake. We conclude that the circadian rhythm in PEFR is often in phase with the timing of sleep but sleep does not cause nocturnal asthma. Disruption of sleep therefore has no apparent value in the treatment of nocturnal asthma.
Association between sleep duration and asthma in different weight statuses (CHNS 2009-2015). [2021]Inadequate sleep duration affects asthma and weight. The associations among sleep duration, asthma, and different weight statuses in the Chinese population need to be further determined.
Assessing sleep quality and daytime wakefulness in asthma using wrist actigraphy. [2008]This study evaluated the sleep/wake cycle of individuals with asthma in relation to asthma control, daytime sleepiness, and daytime activity. Ten persons with mild to moderate persistent asthma monitored their sleep quality and daytime wakefulness for 7 consecutive days using 24-hours wrist actigraphy. Degree of asthma control strongly correlated with sleep quality. Individuals whose asthma was not well controlled took longer to fall asleep, awoke more often, and spent more time awake during the night compared to those with well controlled asthma. Poor asthma control, use of rescue medications, and asthma symptoms were associated with daytime sleepiness and limitations in physical activity and emotional function. Forty percent of subjects reported clinically significant daytime sleepiness. Evaluating asthma throughout a 24-hour cycle provides valuable information on variations in the sleep/wake cycle associated with asthma control, use of rescue medications, and asthma symptoms.
Sleep disturbances and asthma control: a real life study. [2016]The objective of the present study was to investigate the level of asthma control in real life and the relationship between Asthma Control Test (ACT) scores and sleep disturbances. Patients on control visits for bronchial asthma were asked to complete the ACT questionnaire and to answer 5 questions about their sleep quality (S5). It was found that asthma control was unsatisfactory in 44%. In all ACT classes the level of asthma control appeared to be inversely related to the presence of sleep disturbances: patients with good control reported less frequent and less severe sleep disturbances than uncontrolled subjects. However, a significant percentage of subjects (11-20%) with total control of asthma still had sleep disturbances that resulted in an impaired quality of life. Therefore in any asthma case with sleep disturbances a broader investigation is required whether that impairment is actually a result of asthma or some other co-morbidity. Thus it would be useful if patients who reported sleep disturbances despite good/total control of asthma and rhinitis were managed with a holistic clinical approach and underwent nocturnal polysomnographic monitoring.
Self-perceived Sleep Quality and Quantity in Adults With Asthma: Findings From the CosteAsma Study. [2016]Nocturnal asthma symptoms are associated with poor sleep quality, excessive daytime sleepiness, and poor daytime functioning. The aim of this study was to describe self-perceived sleep quality and quantity in asthmatic adults in a real-world setting according to different determinants of patient health status.
Experimental methods to study sleep disruption and immune balance in urban children with asthma. [2023]We describe research methods developed to examine effects of sleep disruption on changes in immune balance, lung function, and cognitive performance in a sample of urban, ethnically diverse children with persistent asthma. Two case examples (8- and 10-year-old males) are presented to highlight methods of the current study and illustrate effects of experimentally disrupted sleep on the immune balance profile (Th1/Th2 cytokines), key sleep variables from polysomnography data, and lung function in our sample.
Sleep disturbances in patients with asthma. [2019]The prevalence of sleep complaints and sleep disturbances was studied prospectively in 98 consecutive adult asthmatic patients (mean age 45 years, 46% men) attending an out-patient clinic by means of questionnaires and sleep diaries. The results were compared with those from an age- and sex-matched group of 226 healthy individuals. The most common sleep disturbances among the asthmatic patients were early morning awakening (51%), difficulty in maintaining sleep (DMS; 44%) and daytime sleepiness (44%). With decreasing asthma control (i.e. increased number of acute asthmatic attacks) there was an increase of DMS, nocturnal wakefulness, nocturnal breathing problems and bronchodilator inhalations at night. A decrease in estimated sleep time (P less than 0.05) and increase in nocturnal wakefulness (P less than 0.05) was seen with decreasing daytime FEV1--measured as percentage of the predicted value (%FEV1). There was also significant correlation between increasing age and decreasing %FEV1 (P less than 0.01). Among the 26 patients who were only taking one oral bronchodilator, no definite difference regarding sleep quality was found between those treated with theophylline and those taking an oral beta 2-agonist. The prevalence rates of DIS, DMS and daytime sleepiness were about twice as high among the asthmatic patients than in the healthy population. It is concluded that impaired quality of sleep, with disturbed sleep during the night, early morning awakenings and daytime sleepiness, is common among patients with bronchial asthma.
Neuropsychological outcomes of nocturnal asthma. [2019]In spite of frequent reports that nocturnal asthma results in fatigue and impaired cognitive performance, there exists little objective evidence as to the daytime consequences of this disorder. Treatment studies have established that the symptoms of nocturnal asthma improve with medication intervention, but performance does not. Studies of obstructive sleep apnea (OSA), a source of generally more severe sleep fragmentation, have demonstrated that measurement of sleep-deprivation effects is limited to tasks requiring heightened alertness and rapid information processing, and that the degree of score change is related to the degree of sleep disruption. Studies of normal, but sleep-deprived, subjects indicate that (1) utilization of repetitive measures sustained for long duration can potentiate motivation to overcome the effects of fatigue in the laboratory, and (2) even when average scores do not change significantly, performance becomes more irregular. These collective findings about the measurement of performance impairment secondary to sleep deprivation can be used to guide new studies of nocturnal asthma. Finally, children must be included in future investigations because they may be at even greater risk for daytime consequences of nocturnal asthma than adults.
Sleep disturbances in clinically stable young asthmatic adults. [2015]Although nocturnal asthma is a well documented clinical problem, the effect of asthma on sleep itself and morbidity caused thereby have not received adequate attention. It is now recognized that partial sleep deprivation has a considerable effect on human functions.