NCT01837459|Completed
A Research Study for Children About Heart Changes and Obstructive Sleep Apnea (OSA)
Vascular Function in Children With Obstructive Sleep Apnea
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Vascular Function in Children With Obstructive Sleep Apnea
Sponsor study identifier
Secondary identifiers
observational
231
1 country
1
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)In this research study the investigators want to learn more about the risk of developing blood vessel and heart disease from night-time sleep apnea. Sleep apnea is a condition that results from blocking of the throat during sleep. This study examines changes in blood pressure, blood vessel stiffness, heart size and levels of specific substances in the blood which may cause heart disease. This study is for children ages 5 to 13 years. The study involves 3 visits over 18 months. The first and last visits include an overnight sleep study (polysomnography or PSG). All the visits will include:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 8, 2013
Actual (reported)April 23, 2013
Actual (reported)December 2015
Actual (reported)December 2015
Actual (reported)Comparison across groups of change in levels of C-reactive protein and cytokines
Baseline, 9 months, 18 months
Comparison across groups of changes in carotid and aortic compliance and stiffness as measured in changes in pulse waves, and carotid intima media thickness (mm)
Baseline, 9 months, 18 months
Obese with Apnea Hypopnea index (AHI) \<1
Obese and with AHI\>1
Non-obese with AHI\<1
Non-obese with AHI\>1
Children 5-13 years recruited from the community, otolaryngology and sleep disorder clinics
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Witter AM, Smith DF, Khan MTF, Nakamura A, Schuler CL, DiFrancesco MW, Hossain MM, Amin RS. Relationship of Circadian Blood Pressure Dysregulation With Left Ventricular Structure and Function in Children With Obstructive Sleep Apnea. J Sleep Res. 2025 Oct;34(5):e70049. doi: 10.1111/jsr.70049. Epub 2025 Apr 1.
Domany KA, Huang G, Hossain MM, Schuler CL, Somers VK, Daniels SR, Amin R. Effect of Adenotonsillectomy on Cardiac Function in Children Age 5-13 Years With Obstructive Sleep Apnea. Am J Cardiol. 2021 Feb 15;141:120-126. doi: 10.1016/j.amjcard.2020.11.019. Epub 2020 Nov 19.
Serum, plasma, tissue
Raouf Amin, MD
Children's Hospital Medical Center, Cincinnati
231 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2013
First Posted
April 23, 2013
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Ezopiclone Improves the Quality of Overnight Polysomnography
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
April 14, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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