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Prevalence and Correlates of Childhood Sleep Apnea

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

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    July 28, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005560
    Brief Title
    Prevalence and Correlates of Childhood Sleep Apnea
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1999 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    December 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To determine if there are anatomic and physical characteristics that distinguish pre-adolescent children with sleep disordered breathing and if the sleep disordered breathing is associated with adverse effects on school and neurocognitive performance.
    Detailed Description
    BACKGROUND: The study is part of an initiative, Obstructive Sleep Apnea in Children, which was released 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. The goal of the initiative is to define abnormalities in airway structure and function responsible for obstructive sleep apnea in children, ages 3 to 12, and to identify physiological and clinical measures associated with increased morbidity. DESIGN NARRATIVE: A 3 stage stratified sampling procedure is conducted on pre-adolescent Tucson school children between the ages of 6 and 12 years of age. Stratification is performed on the following factors:age, ethnicity, gender and snoring status. In the initial phase, 2500 (625 each year) pre-adolescent Tucson school children between the ages of 6 and 12 years of age are surveyed using a questionnaire designed to elicit symptoms of sleep disordered breathing (SDB) including obstructive sleep apnea (OSA). From these data, a subset of 90 snoring and 30 non-snoring children (500 total) will be recruited each year to have home polysomnography, basic anthropometric measurements and a battery of neurocognitive tests performed in order to identify a group of children with SDB including OSA and a group without this condition. In the third phase of the study, 20 children with SDB and 20 without will be recruited each year (80 total) to undergo more intensive anatomic and physiologic testing including cephalometry, measurement of upper airway geometry and resistance using acoustic reflection and oscillation techniques and control of ventilation studies. The intent of the study is to: 1) determine the prevalence of symptoms of SDB in pre-adolescent Caucasian and Hispanic children; 2) compare the prevalence of objectively measured SDB in pre-adolescent Caucasian and Hispanic children; 3) determine whether there are physiologic and anatomic differences among pre-adolescent children who have SDB including obstructive sleep apnea and upper airway resistance syndrome (UARS) and those who do not during quiet wakefulness; and 4) determine the association between SDB and school performance, neuro-cognitive ability and daytime symptoms. The study has been extended through November 2008 to to follow a large cohort of pre-adolescent children to determine whether untreated sleep apnea is associated with identifiable decrements in neurocognitive performance and school performance, as well as perturbations of blood pressure and growth, at approximately four years after initial enrollment and identification of sleep apnea. The study also aims to identify pre-adolescent anthropometric and ethnic variables associated with future development and/or regression of sleep apnea .The study secondarily aims to determine whether abnormalities in ventilatory drive found in pre-adolescence in children with sleep apnea persist after approximately four years of untreated sleep apnea.

    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
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stuart Quan
    Organizational Affiliation
    University of Arizona

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11766164
    Citation
    Goodwin JL, Enright PL, Kaemingk KL, Rosen GM, Morgan WJ, Fregosi RF, Quan SF. Feasibility of using unattended polysomnography in children for research--report of the Tucson Children's Assessment of Sleep Apnea study (TuCASA). Sleep. 2001 Dec 15;24(8):937-44. doi: 10.1093/sleep/24.8.937.
    Results Reference
    background
    PubMed Identifier
    12853523
    Citation
    Goodwin JL, Babar SI, Kaemingk KL, Rosen GM, Morgan WJ, Sherrill DL, Quan SF; Tucson Children's Assessment of Sleep Apnea Study. Symptoms related to sleep-disordered breathing in white and Hispanic children: the Tucson Children's Assessment of Sleep Apnea Study. Chest. 2003 Jul;124(1):196-203. doi: 10.1378/chest.124.1.196.
    Results Reference
    background
    PubMed Identifier
    14738283
    Citation
    Kaemingk KL, Pasvogel AE, Goodwin JL, Mulvaney SA, Martinez F, Enright PL, Rosen GM, Morgan WJ, Fregosi RF, Quan SF. Learning in children and sleep disordered breathing: findings of the Tucson Children's Assessment of Sleep Apnea (tuCASA) prospective cohort study. J Int Neuropsychol Soc. 2003 Nov;9(7):1016-26. doi: 10.1017/S1355617703970056.
    Results Reference
    background
    PubMed Identifier
    14592355
    Citation
    Quan SF, Goodwin JL, Babar SI, Kaemingk KL, Enright PL, Rosen GM, Fregosi RF, Morgan WJ. Sleep architecture in normal Caucasian and Hispanic children aged 6-11 years recorded during unattended home polysomnography: experience from the Tucson Children's Assessment of Sleep Apnea Study (TuCASA). Sleep Med. 2003 Jan;4(1):13-9. doi: 10.1016/s1389-9457(02)00235-6.
    Results Reference
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    PubMed Identifier
    12963596
    Citation
    Enright PL, Goodwin JL, Sherrill DL, Quan JR, Quan SF; Tucson Children's Assessment of Sleep Apnea study. Blood pressure elevation associated with sleep-related breathing disorder in a community sample of white and Hispanic children: the Tucson Children's Assessment of Sleep Apnea study. Arch Pediatr Adolesc Med. 2003 Sep;157(9):901-4. doi: 10.1001/archpedi.157.9.901.
    Results Reference
    background
    PubMed Identifier
    12938812
    Citation
    Goodwin JL, Kaemingk KL, Fregosi RF, Rosen GM, Morgan WJ, Sherrill DL, Quan SF. Clinical outcomes associated with sleep-disordered breathing in Caucasian and Hispanic children--the Tucson Children's Assessment of Sleep Apnea study (TuCASA). Sleep. 2003 Aug 1;26(5):587-91. doi: 10.1093/sleep/26.5.587.
    Results Reference
    background
    PubMed Identifier
    12897029
    Citation
    Fregosi RF, Quan SF, Kaemingk KL, Morgan WJ, Goodwin JL, Cabrera R, Gmitro A. Sleep-disordered breathing, pharyngeal size and soft tissue anatomy in children. J Appl Physiol (1985). 2003 Nov;95(5):2030-8. doi: 10.1152/japplphysiol.00293.2003. Epub 2003 Aug 1.
    Results Reference
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    PubMed Identifier
    15117413
    Citation
    Fregosi RF, Quan SF, Jackson AC, Kaemingk KL, Morgan WJ, Goodwin JL, Reeder JC, Cabrera RK, Antonio E. Ventilatory drive and the apnea-hypopnea index in six-to-twelve year old children. BMC Pulm Med. 2004 Apr 29;4:4. doi: 10.1186/1471-2466-4-4.
    Results Reference
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    PubMed Identifier
    15115546
    Citation
    Goodwin JL, Kaemingk KL, Fregosi RF, Rosen GM, Morgan WJ, Smith T, Quan SF. Parasomnias and sleep disordered breathing in Caucasian and Hispanic children - the Tucson children's assessment of sleep apnea study. BMC Med. 2004 Apr 28;2:14. doi: 10.1186/1741-7015-2-14.
    Results Reference
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    Prevalence and Correlates of Childhood Sleep Apnea

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