NCT00560859

Childhood Adenotonsillectomy Study for Children With OSAS

A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Because adenotonsillectomy is the usual treatment for OSAS, all children in the study will get surgery. However, in order to assess the extent to which adenotonsillectomy surgery improves breathing disturbances and sleep quality in children with OSAS, two groups will be studied. One group will get surgery early (one month after enrollment) and the other group will be re-evaluated for surgery within 7 months of enrollment. Children in both groups will be closely monitored through the 7-8 month study period and sleep and health educational materials will be provided to assist in establishing healthy habits.

Conditions

• Obstructive Sleep Apnea
• Snoring

Interventions

Type	Name	Description
PROCEDURE	Adenotonsillectomy (AT) - removal of adenoids and tonsils	Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils
OTHER	Watchful Waiting	Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Timeline

• Start date: 2007-10-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2007-11-20
• Last updated: 2015-12-15
• Results posted: 2015-12-15

Locations

6 sites across 1 country: United States