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Mechanisms Mediating Cardiovascular Disease in Children With Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00059111
First Posted: April 18, 2003
Last Update Posted: May 4, 2017
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Children's Hospital Medical Center, Cincinnati
  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

Study Type: Observational

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 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): NCT00059111


Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Raouf Amin Children's Hospital & Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00059111     History of Changes
Other Study ID Numbers: 1212
R01HL070907-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 17, 2003
First Posted: April 18, 2003
Last Update Posted: May 4, 2017
Last Verified: May 2017

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