Sponsor study identifier
observational
250
1 country
1
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedObesity has reached epidemic proportions in the United States with roughly 20% of American children being overweight and has serious consequences such as sleep apnea.Additionally, obesity is known to result in the earlier onset of puberty . Thus, it can be expected that obese children take-on adult characteristics at an earlier chronologic age than their non-obese counterparts. Current guidelines recommend adenotonsillectomy (T+A) as primary and effective therapy for sleep apnea resulting in polysomnographic resolution in 75-100% of patients. Small studies have shown that T+A relieves symptoms in obese children but surgical intervention has been less efficacious in adults. We hypothesize that T+A may be less efficacious in obese adolescents because of earlier onset of puberty imparting more adult characteristics. We further hypothesize that the efficacy of T+A will correlate more closely with Tanner staging than with chronologic age because of the earlier onset of sexual maturation associated with obesity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 15, 2005
Actual (reported)September 22, 2005
Actual (reported)Contact the study team to confirm eligibility.
University of Rochester
Rochester, New York, 14642, United States
Heidi V. Connolly, MD
University of Rochester
Margaret-Ann Carno, PhD,RN
University of Rochester
250 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2005
First Posted
September 22, 2005
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea
Last Updated
February 13, 2009
Record last verified: 2006-09
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Source: ClinicalTrials.gov.
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