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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT05420766
Status
Recruiting

Conditions

  • Asthma in Children
  • Sleep Hygiene
  • Sleep, Inadequate

Eligibility Criteria

Sex
ALL
Age
7 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Shortened Sleep — BEHAVIORAL
    In this experimental condition, children go to bed 90 minutes later than their typical bedtime during Week 2 of the 4-week protocol.
  • Stabilized sleep — BEHAVIORAL
    In this control condition, children go to bed at their usual time throughout the 4-week protocol.

Study Details

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.

Key Dates

Start date
May 15, 2022
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Shortened Sleep
    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.
  • Active Comparator: Usual Sleep Schedule
    In this control arm of the 4-week sleep protocol, children follow the Stabilized Sleep schedule for all 4 weeks.

Primary Outcome Measure

10mL of heparinized blood [ Time Frame: Changes in immune function across Days 7, 11, 14, 21 and 28 of the 4-week sleep protocol ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02903
Daphne Koinis-Mitchell, PhD
401-793-8632
Sheryl J Kopel, MSc
401-444-7217

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