CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 453 enrolled
Drug / intervention
Adenotonsillectomy (AT) - removal of adenoids and tonsils +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00560859
NCT00560859N/ACompleted
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A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome

University of Pennsylvania·interventional·Posted Nov 20, 2007·Updated Dec 15, 2015

In Brief

A clinical study evaluating Adenotonsillectomy (AT) - removal of adenoids and tonsils and Watchful Waiting for Obstructive Sleep Apnea and Snoring. Completed, enrolled 453 participants across 6 sites.

Detailed Summary

The purpose of this research is to determine the effect of adenotonsillectomy surgery (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children. OSAS can cause health problems including poor growth, high blood pressure, diabetes and behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve afterwards. This study will help determine if improvement occurs or if it does not. It will also look at whether certain groups, such as children who are overweight or of different ethnicities, are helped by the surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea, Snoring
CountriesUnited States
CollaboratorsHarvard University, University of Michigan, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2007
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.6 years ago

Interventions

Adenotonsillectomy (AT) - removal of adenoids and tonsilsprocedure

Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils

Watchful Waitingother

Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.