We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence and Correlates of Childhood Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005560
First Posted: May 26, 2000
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition
Lung Diseases Sleep Apnea Syndromes

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 1999
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005560


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Stuart Quan University of Arizona
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005560     History of Changes
Other Study ID Numbers: 5106
R01HL062373 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: July 29, 2016
Last Verified: January 2008

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