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NCT01301989 · ClinicalTrials.gov registry record · NA

Reducing Sleep Disparities in Minority Children

A NA study, sponsored by Columbia University.

Completed
Registry status
NA
Development phase
90
Enrollment target

NCT01301989: Completed NA study, sponsored by Columbia University.

NCT01301989 is a NA study that has completed, run by Columbia University. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01301989, a NA study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
NA
Development phase
90 participants
Enrollment target

Study Summary

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 interv

Primary Outcome

The primary outcome is nightly sleep duration and is objectively measured using actigraphy. The actigraph is worn on the non-dominant wrist for 7 consecutive days and nights. Actigraphy is a well-validated method for evaluating sleep and circadian rhythm patterns in children. It is highly correlated with polysomnography. To reduce potential confounders, Actiwatches are worn 5 times during the study, at baseline and at 3, 6, 9, 12 months following collection of baseline data.

Interventions

  • BEHAVIORAL Sleep Counselor Intervention
  • OTHER Sleep Education Control

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2010-07
Est. Completion 2014-08
Phase NA
Columbia University

958 total trials

What the finished NCT01301989 record still lists

NCT01301989 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Sleep Counselor Intervention is the first listed.

NCT01301989 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01301989 about?

NCT01301989 is a clinical study titled "Reducing Sleep Disparities in Minority Children". 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...

What is the current status of trial NCT01301989?

This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2010-07. Estimated completion is 2014-08.

What interventions are being tested in trial NCT01301989?

The interventions under investigation include: Sleep Counselor Intervention (BEHAVIORAL), Sleep Education Control (OTHER).

Who is sponsoring clinical trial NCT01301989?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01301989's enrollment target sits among peer trials

90 941st of 2000 higher than 1,029 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01301989, the US trial registry maintained by the National Library of Medicine. NCT01301989 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.