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Mechanisms Mediating Cardiovascular Disease in Children with Obstructive Sleep Apnea - Article


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International Classification of Diseases

ICD-10


Clinical Trial: Mechanisms Mediating Cardiovascular Disease in Children with Obstructive Sleep Apnea

This study is no longer recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

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

Condition
Cardiovascular Diseases
Heart Diseases
Sleep Apnea Syndromes
Lung Diseases
Hypertension

MedlinePlus related topics:  Heart Diseases;   Heart Diseases--Prevention;   High Blood Pressure;   Respiratory Diseases;   Sleep Apnea;   Vascular Diseases

Study Type: Observational
Study Design: Natural History, Longitudinal

Further Study Details: 

Study start: April 2003;  Study completion: March 2008

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   -   12 Years,  Genders Eligible for Study:  Both

Criteria

No eligibility criteria

Location Information

Study chairs or principal investigators

Raouf Amin,  Children's Hospital Medical Center   

More Information

Publications

Amin RS, Kimball TR, Kalra M, Jeffries JL, Carroll JL, Bean JA, Witt SA, Glascock BJ, Daniels SR. Left ventricular function in children with sleep-disordered breathing. Am J Cardiol. 2005 Mar 15;95(6):801-4.

Study ID Numbers:  1212
Record last reviewed:  March 2005
Last Updated:  March 24, 2005
Record first received:  April 17, 2003
ClinicalTrials.gov Identifier:  NCT00059111
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 10, 2008



Page Updated: November 22, 2004
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