Epidemiology of Sleep Disordered Breathing in Children
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|ClinicalTrials.gov Identifier: NCT00005516|
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 18, 2016
|Condition or disease|
|Lung Diseases Sleep Apnea Syndromes|
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.
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.
|Study Type :||Observational|
|Study Start Date :||July 1998|
|Actual Study Completion Date :||June 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005516
|OverallOfficial:||Susan Redline||Case Western Reserve University|