Pilot Study to Assess the Effectiveness of Tonsil and Adenoidectomy (T+A) in Overweight Children and Adolescents
Completed
Conditions studied: Obesity, Obstructive Sleep Apnea Syndrome
In brief
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.
Key facts
- Study ID
- NCT00222963
- Run by
- University of Rochester
- People needed
- 250
- Starts
- 2004-09-01
- Last updated by the study team
- 2009-02-13
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children aged 8-18 who are overweight or at risk for overweight (defined as BMI >85%ile for age and gender referred for evaluation and treatment of sleep apnea.
You may not qualify if…
- Children with underlying craniofacial anomalies, chromosomal abnormalities, neuromuscular disorders and metabolic disorders except diabetes will be excluded. Children and parents who do not speak or write English will be excluded. Children with neuropsychiatric disabilities severe enough to preclude sufficient cooperation with overnight polysomnography will also be excluded.
Where it is running
- University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
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