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Neurobehavioral Consequences of Sleep Apnea in Children

Primary Purpose

Lung Diseases, Sleep Apnea Syndromes

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lung Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 2, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006323
    Brief Title
    Neurobehavioral Consequences of Sleep Apnea in Children
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To identify physiological and clinical measures of obstructive sleep-disordered breathing that are associated with increased morbidity in children.
    Detailed Description
    BACKGROUND: The study is in response to a Request for Applications (RFA) on Obstructive Sleep Apnea in Children. NHLBI issued the RFA in December, 1997, with co-sponsorship from the National Institute of Dental and Craniofacial Research and the National Institute of Child Health and Human Development. DESIGN NARRATIVE: This cross-sectional study recruited a population-based sample of young children from among the more than 8000 children in Massachusetts enrolled in the on-going Infant Care Practices Study. Stratified sampling was used to assemble a cohort of 250 children with habitual snoring (> 3 nights/week), 100 children with occasional snoring (<3 nights/week), and 100 non-snoring children. These children were studied within 3 months of their fourth birthday using overnight laboratory polysomnography and a detailed neurobehavioral evaluation, in order to test the hypothesis that, after adjusting for potential confounding variables, both parent-reported snoring and polysomnographic measures were associated with standardized measures of the following neurobehavioral domains: immediate attention, sustained attention, working memory, and symptoms of hyperactivity. These data also provided an opportunity to determine normal values for polysomnographic measures in 4-year-old children and to determine the prevalence of snoring and polysomnographic abnormalities among 4-year-old 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Sleep Apnea Syndromes

    7. Study Design

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Gottlieb
    Organizational Affiliation
    Boston University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14523179
    Citation
    Gottlieb DJ, Vezina RM, Chase C, Lesko SM, Heeren TC, Weese-Mayer DE, Auerbach SH, Corwin MJ. Symptoms of sleep-disordered breathing in 5-year-old children are associated with sleepiness and problem behaviors. Pediatrics. 2003 Oct;112(4):870-7. doi: 10.1542/peds.112.4.870.
    Results Reference
    background
    PubMed Identifier
    15480367
    Citation
    Gottlieb DJ, Chase C, Vezina RM, Heeren TC, Corwin MJ, Auerbach SH, Weese-Mayer DE, Lesko SM. Sleep-disordered breathing symptoms are associated with poorer cognitive function in 5-year-old children. J Pediatr. 2004 Oct;145(4):458-64. doi: 10.1016/j.jpeds.2004.05.039.
    Results Reference
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    Neurobehavioral Consequences of Sleep Apnea in Children

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