Obstructive Sleep Apnea Clinical Trial
Official title:
A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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