Neurocognitive Function in Snoring Children

April 6, 2017 updated by: University of Louisville
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).

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with attention deficit hyperactivity disorder

Description

Subjects with ADHD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: David Gozal, University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 1999

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 2, 2000

First Submitted That Met QC Criteria

October 2, 2000

First Posted (Estimate)

October 3, 2000

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 924
  • R01HL065270 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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