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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

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

AIMS Trial 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.Check my eligibility

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.See study design

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.

AIMS Trial 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.

AIMS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

10mL of heparinized blood

Secondary outcome measures

Forced Expiratory Flow in 1 second (FEV1) % predicted

Other outcome measures

Time in Bed actigraphy scores

AIMS 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER

456 Previous Clinical Trials

558,140 Total Patients Enrolled

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,803 Total Patients Enrolled

University of Mississippi Medical CenterOTHER

174 Previous Clinical Trials

195,183 Total Patients Enrolled

Media Library

Childhood Asthma Research Study Groups: Shortened Sleep, Usual Sleep Schedule

Childhood Asthma Clinical Trial 2023: Shortened Sleep Highlights & Side Effects. Trial Name: NCT05420766 — N/A

Shortened Sleep 2023 Treatment Timeline for Medical Study. Trial Name: NCT05420766 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of participants in this experimental treatment?

"Affirmative. The information hosted on clinicaltrials.gov indicates that this medical trial is actively enrolling participants, which began posting on May 15th 2022 and was recently updated on June 13th 2022. 204 patients need to be recruited from a single site."

Answered by AI

Is it feasible for individuals aged 80 or more to join in this experiment?

"This clinical trial has an age requirement of 7 to 9 years old."

Answered by AI

Who qualifies to partake in this test?

"This clinical trial, which is looking for 204 children aged 7 to 9 years old with sleep hygiene, has specific criteria that must be met. This includes having physician-verified asthma and passing a skin allergy test; furthermore, the primary caregiver of the participant needs to speak English and they need show evidence of obtaining between nine and eleven hours of rest daily in the past month. The participants also have to reside or attend school in one of ten particular urban areas outlined. Those who do not possess an asthma diagnosis nor are taking medications used to manage its symptoms will not qualify either."

Answered by AI

Are there still spots available for this research study?

"Affirmative. The clinicaltrials.gov database lists this trial as actively recruiting patients. It was first posted on May 15th 2022 and last updated on June 13th 2022, looking to enroll 204 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Sleep Duration on Immune Balance in Urban Children With Asthma

2022. "Impact of Sleep Duration on Immune Balance in Urban Children With Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05420766.

All > Sleep Deprivation