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Sleep Duration for Asthma (AIMS Trial)

N/A

Recruiting

Led By Daphne Koinis-Mitchell, PhD

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets criteria for current persistent asthma with a current prescription for an asthma controller medicine

Children 7-10 years-old

Must not have

Asthma-related emergency department visit and/or asthma-related hospitalization in past 90 days

Diagnosed ADHD; Use of stimulants to treat ADHD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes in immune function across days 7, 11, 14, 21 and 28 of the 4-week sleep protocol

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of shortened and recovery sleep on immune balance and associated changes in lung function in urban children with allergic asthma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves manipulating sleep patterns rather than medication side effects aren't discussed as typical drug reactions but may include changes in mood or behavior due to altered sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My child is between 7 and 10 years old.

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My doctor says I have asthma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have ADHD and am taking stimulants for it.

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I am in the mid to late stages of puberty.

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My asthma is severe and not well-managed.

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I do not use medication to control asthma.

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I have another lung disease or immune system disorder.

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I haven't taken steroids for the last 30 days.

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I have never been diagnosed with asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes in immune function across days 7, 11, 14, 21 and 28 of the 4-week sleep protocol

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes in immune function across days 7, 11, 14, 21 and 28 of the 4-week sleep protocol

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in immune function across days 7, 11, 14, 21 and 28 of the 4-week sleep protocol for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

10mL of heparinized blood

Secondary study objectives

Forced Expiratory Flow in 1 second (FEV1) % predicted

Other study objectives

Time in Bed actigraphy scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met