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Mechanisms Mediating Cardiovascular Disease in Children With Obstructive Sleep Apnea
This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00059111
  Purpose

To identify the early effects of obstructive sleep apnea on the cardiovascular system of children.


Condition Phase
Cardiovascular Diseases
Heart Diseases
Sleep Apnea Syndromes
Lung Diseases
Hypertension
N/A

MedlinePlus related topics: Heart Diseases High Blood Pressure Sleep Apnea
U.S. FDA Resources
Study Type: Observational

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

Study Start Date: April 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Obstructive sleep apnea (OSA) is an important clinical disorder occurring in men, women, and children with a prevalence of 4 percent, 2 percent and 1-3 percent, respectively. OSA is under active study in adults and is definitely linked with increased cardiovascular morbidity, even in its mild to moderate clinical forms. In contrast, OSA has not been well studied in children and the potential deleterious consequences on cardiovascular function have received little or no attention.

DESIGN NARRATIVE:

The study will examine in children 1) The interaction between OSA and baroreflex dysfunction, 2) The relation of OSA severity and baroreflex dysfunction to abnormalities in blood pressure control during wakefulness and sleep, 3) The association of the diminished baroreflex gain and impaired blood pressure control with an index of end organ damage, the left ventricular mass index, and 4) Whether effective treatment of OSA results in significant improvement in baroreceptor function, blood pressure control and a decrease in left ventricular mass index. A cross-sectional study will be conducted in 8-12 year old children with OSA and a matched group of normal children. Studies include baroreceptor function, 24-hour ambulatory blood pressure and left ventricular mass index. Baroreceptor function will be measured by non-invasive techniques based on combined computer analysis of heart rate and blood pressure measured by portapres. 24-hour ambulatory blood pressure will be measured by a Spacelab monitor and left ventricular mass index will be measured by direct M-mode echocardiogram. A longitudinal study will be conducted on the effect of adequate treatment of OSA on baroreceptor function, daytime and nocturnal blood pressure and left ventricular mass index. A cohort of children with OSA and a matched group of normal controls will be followed for a period of 12 months after treatment of the disorder. Results are expected to show that children with OSA have decreased baroreceptor sensitivity, elevated nocturnal blood pressure and increased left ventricular mass index and that effective therapy for OSA, as determined by polysomnography, will improve or normalize baroreceptor sensitivity as well as nocturnal blood pressures and will lead to a decrease in left ventricular mass index.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059111

Sponsors and Collaborators
Investigators
Investigator: Raouf Amin Children's Hospital Medical Center
  More Information

Publications:
Study ID Numbers: 1212
Study First Received: April 17, 2003
Last Updated: April 22, 2008
ClinicalTrials.gov Identifier: NCT00059111  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Sleep Apnea Syndromes
Heart Diseases
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Vascular Diseases
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Lung Diseases
Signs and Symptoms, Respiratory
Hypertension

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009