Lung Diseases Clinical Trial
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.
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.
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