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Neurocognitive Function in Snoring Children

This study has been terminated.
(PI left the university)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00006321
First received: October 2, 2000
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
To assess associations between behavioral/neuropsychological measures and various measures of sleep disordered breathing (SDB) and to determine the prevalence of SDB in children with Attention Deficit Hyperactivity Disorder (ADHD).

Condition
Lung Diseases Sleep Apnea Syndromes Neurologic Manifestations

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Louisville:

Enrollment: 40
Actual Study Start Date: September 1999
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Obstructive sleep apnea syndrome (OSAS) is a relatively frequent condition which may affect up to 2-3 percent of school age children. The morbidity of untreated OSAS may include failure to thrive, pulmonary and systemic hypertension, and behavioral and neurocognitive deficiencies. However, it remains unclear to what extent OSAS impinges on aspects of neurocognitive and behavioral function, and whether sleep fragmentation, intermittent hypoxemia, and alveolar hypoventilation, which are the three major physiological alterations in OSAS, selectively affect particularly vulnerable components of neurocognitive function. Furthermore, certain similarities exist between the behavioral alterations occurring in OSAS and those seen in children with the Attention Deficit Hyperactivity Disorder (ADHD).

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:

The cross-sectional study tested the hypothesis that OSAS is detrimental to particular aspects of neurocognitive and behavioral functioning. Snoring 6 year-old children attending the public elementary school system in New Orleans Parish were prospectively identified by an appropriate questionnaire and enrolled in the study. Snoring children underwent overnight polysomnographic assessment to determine the presence and severity of OSAS, and their neurocognitive and behavioral functions were subsequently evaluated employing the Wechsler Intelligence Scale for Children-III, the Conners' Continuous Performance Test, and the Cambridge Neuropsychological Test Automated Battery test. Multivariate regression and analyses of variance allowed for determination of aspects of neurocognitive function and behavior that were vulnerable to OSAS in general, and to each of OSAS components in particular.

The study also tested the hypothesis that children with ADHD may have increased prevalence of snoring and OSAS. Children with this diagnosis were initially confirmed as having ADHD using the revised Diagnostic Interview for Children and Adolescents, the Conners' Parent Rating Scale, and the Child Behavior Checklist. ADHD children then underwent polysomnographic evaluation as well as extensive evaluation of neurocognitive function and behavior as above. The prevalence of snoring and OSAS were then calculated.

The study was extended through June 2007 to test the hypothesis that SDB will induce systemic inflammatory responses, and that the magnitude of such inflammatory response will be the major determinant of the severity of neurocognitive dysfunction associated with SDB.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with attention deficit hyperactivity disorder
Criteria
Subjects with ADHD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006321

Sponsors and Collaborators
University of Louisville
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: David Gozal University of Louisville
  More Information

Publications:

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00006321     History of Changes
Other Study ID Numbers: 924
R01HL065270 ( U.S. NIH Grant/Contract )
Study First Received: October 2, 2000
Last Updated: April 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Sleep Apnea Syndromes
Neurologic Manifestations
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 25, 2017