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OpenTrials
Completed

NCT Number: NCT00005516

Epidemiology of Sleep Disordered Breathing in Children

To collect fundamental data regarding the distribution of measures of sleep disordered breathing (SDB) in a pediatric population, prevalence of clinically significant SDB in children, risk factors, and associated co-morbidity.

Completed

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Key information

About this study

BACKGROUND:

Developing strategies for recognizing and treating children with Sleep Disordered Breathing (SDB) was not possible in the absence of essential epidemiological data that addressed the distribution of measures of SDB in pediatric populations. The potential public health importance of this was underscored by preliminary data that suggested that risk of SDB was increased in susceptible populations, in particular in African Americans and in children born prematurely.

DESIGN NARRATIVE:

The design was that of a cohort study with a nested case control arm. Sleep disordered breathing was evaluated in 850 children with in-home state-of-the art respiratory monitoring techniques. A number of risk factors were evaluated: sociodemographic characteristics; anthropometry; upper and lower airway size and function (questionnaire, spirometry, and reflectometry); perinatal exposures (from neonatal records); family history; and home environment (passive smoking; sleep patterns, maternal-child stress indices). Behavior, cognitive skills, attention, and health-related quality of life were assessed with standardized instruments to assess co-morbidities (potential SDB outcomes). Analysis of the longitudinal data provided cognitive-developmental trajectories that were evaluated in relationship to SDB. The case-control arm confirmed and extended the findings of the in-home assessments with comprehensive laboratory polysomnography, cephalometry, and objective measures of sleepiness (Multiple Sleep Latency Tests) in three groups of children: definite SDB by home assessment; equivocal SDB; and no SDB. Collection of comprehensive polysomnographic data helped to identify which measures best discriminated symptomatic (e.g., snoring, sleepy) from asymptomatic children.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

No eligibility criteria

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start
1998
Study completion
2002
First posted
May 26, 2000
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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