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Epidemiology of Sleep Disordered Breathing in Children

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Sleep Apnea Syndromes
Lung Diseases

Study type

Observational

Funder types

NIH

Identifiers

NCT00005516
5035
R01HL060957 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

Under 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

No eligibility criteria

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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