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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00222963
Other study ID # 10297
Secondary ID
Status Completed
Phase N/A
First received September 15, 2005
Last updated February 12, 2009
Start date September 2004

Study information

Verified date September 2006
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Obesity 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.


Description:

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Study Design

Time Perspective: Prospective


Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

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