Effects of Sleep Duration on Immune Balance in Urban Children with Asthma
Impact of Sleep Duration on Immune Balance in Urban Children With Asthma
This study tests how different amounts of sleep affect asthma symptoms and immune health in urban children aged 7-11 with allergic asthma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 7 Years to 11 Years |
| Sex | All |
| Sponsor | Rhode Island Hospital Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05420766 on ClinicalTrials.gov |
What this trial studies
This research examines how sleep duration affects immune balance and lung function in urban children aged 7-11 with allergic asthma. The study involves a 4-week experimental design where participants will experience different sleep conditions, including shortened and stabilized sleep. The goal is to understand the relationship between sleep duration and asthma symptoms, particularly focusing on immune responses that may contribute to asthma morbidity. By targeting sleep as a modifiable behavior, the study aims to fill a critical gap in asthma management for urban children.
Who should consider this trial
Good fit: Ideal candidates are urban children aged 7-11 years with physician-diagnosed persistent allergic asthma who currently obtain adequate sleep.
Not a fit: Patients without a diagnosis of asthma or those with severe persistent asthma that is poorly controlled may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved asthma management strategies by highlighting the importance of sleep hygiene in urban children.
How similar studies have performed: While the relationship between sleep and immune function has been explored in adults, this specific approach in urban children with asthma is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Children 7-11 years old * Has physician-diagnosed asthma, per parent and pediatrician report * Meets criteria for current persistent asthma with a current prescription for an asthma controller medicine * Obtains 9.0-11.0 h of sleep per 24 h day in the past month * Has a positive allergy skin test performed at the clinic visit * Resides and attend school in one of the targeted urban areas (Rhode Island: East Providence, North Providence, Providence, Warwick, Cranston, Woonsocket, Central Falls, Pawtucket, Lincoln, Johnston. Massachusetts: Attleboro, North Attleboro, Fall River. * Has a primary caregiver who speaks English Exclusion: * No asthma diagnosis * No use of asthma controller medication * Severe persistent asthma that is poorly controlled * Diagnosis of additional pulmonary disease or medical condition or immune deficiency disorders * Use of systemic steroids \<30 days of screening * Asthma-related emergency department visit and/or asthma-related hospitalization in past 90 days * Marked developmental delay, psychiatric conditions, academic/behavioral problems, learning disabilities * Tanner stage 3-5 of pubertal development * Diagnosed ADHD; Use of stimulants to treat ADHD * An Apnea-Hypoxia Index \>5 (indicator of sleep disordered breathing)
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Daphne Koinis-Mitchell, PhD — Rhode Island Hospital
- Study coordinator: Daphne Koinis-Mitchell, PhD
- Email: dkoinismitchell@lifespan.org
- Phone: 401-793-8632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.