View Clinical Trial (Medical Research Study)
Reducing Sleep Disparities in Urban, Minority School-Aged Children
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10032 |
| Conditions: |
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Sleep Behaviors |
| Purpose: |
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Inadequate sleep is a major health problem of childhood that often fails to receive
attention until significant neurobehavioral and other health problems are noted. Although
adequate sleep is essential for normal growth and brain development, studies show that
children from minority and economically disadvantaged families are more likely to experience
shorter sleep times and more sleep fragmentation compared to their Caucasian and
economically advantaged counterparts. As a result, they are disproportionately affected by
the adverse health and quality of life consequences of poor sleep. There are currently no
intervention studies to the investigators knowledge aimed at addressing sleep disparities by
improving sleep duration and sleep hygiene in early school-aged children from minority
populations. This study seeks to close the 'sleep gap' that exists between the sleep
duration of minority school-aged children and that of their non-minority peers. An
interdisciplinary team of researchers and clinicians from Columbia University's Pediatric
Lung and Sleep Disorders Center, School of Public Health, Psychiatry Department, and two
outpatient clinic systems affiliated with Columbia are collaborating to reduce sleep
disparities by improving sleep duration in a group of 5-6 year old minority children. The
primary goal of this study is to evaluate the efficacy of a tailored, interactive,
educational and behavioral intervention that utilizes trained sleep counselors to assist
parents in improving their children's sleep hygiene and reducing risk factors for poor
sleep, thereby increasing sleep duration over a 12-month period in a randomized controlled
trial of children identified with sleep problems (Aim 1). The investigators will screen 375
parents of 5-6 year old children from 5 primary care clinics to identify children with and
without sleep problems and enroll 90 of the 375 children screened who have sleep problems in
a randomized controlled trial of an in-home sleep intervention. Using an initial home
assessment, baseline actigraphy (motion monitor) data, sleep logs recorded by parents, and
information regarding risk factors for poor sleep collected from each family during
screening, the investigators will work with parents of children randomized to the
intervention group to develop a personalized sleep plan for their children. The
investigators will evaluate the impact of the intervention on: a) nightly sleep duration; b)
neurocognitive function; and c) behavioral disorders.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Healthy child age 5-6 years old
- School enrollment for a minimum of 5 hours/day
- Positive Children's Sleep Habits Questionnaire (score ≥ 41)
- Permanent housing for the previous 12 months
- Permission for research staff to complete 5-9 home over 1 year
- Have telephone access or a contact with telephone access
- Fluent in either English or Spanish
Exclusion Criteria:
- Serious co-morbid condition that may impact sleep including:
- genetic syndromes
- neuromuscular disorders
- seizure disorder
- mental retardation
- autism
- severe learning disabilities
- psychiatric disorders
- attention-deficit/hyperactivity disorder
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| NCT ID: |
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NCT01301989 |
| Primary Contact: |
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Principal Investigator
Beverley J Sheares, MD, MS
Columbia University
Beverley J Sheares, MD, MS
Phone: 212-305-5122
Email: bjs4@columbia.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10032
United States
Sheares
Phone: 212-305-5122
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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