|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborators: |
Harvard University University of Michigan National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by (Responsible Party): | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00560859 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Snoring |
Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils Other: Watchful Waiting |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome |
| Estimated Enrollment: | 460 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Early AT Surgery
Children will be closely monitored and receive adenotonsillectomy (AT) within 4 weeks of the baseline visit.
|
Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils
Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
Other Name: EAT
|
|
Watchful Waiting
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
|
Other: Watchful Waiting
Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
Other Name: Watchful Waiting with Supportive Care (WWSC)
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Cardinal Glennon Children's Medical Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Montefiore Children's Hospital | |
| New York, New York, United States, 10467 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Rainbow Babies & Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19401 | |
| Study Chair: | Susan Redline, MD, MPH | Harvard University |
| Study Director: | Susan Ellenberg, Ph.D. | University of Pennsylvania |
| Principal Investigator: | Ron Chervin, MD, MS | University of Michigan |
| Study Director: | Bruno Giordani, PH.D. | Univeristy of Michigan |
| Study Director: | Susan Garetz, MD | University of Michigan |
| Principal Investigator: | Raouf Amin, MD | Cincinnati Children's Hopsital Medical Center (CCHMC) |
| Principal Investigator: | Carole Marcus, MBB Ch. | Children's Hospital of Philadelphia (CHOP) |
| Principal Investigator: | Carol Rosen, MD | Case University School of Medicine; Rainbow Babies & Children's Hospital |
| Principal Investigator: | Ron Mitchell, MD | Cardinal Glennon Children's Medical Center, St. Louis MO |
| Principal Investigator: | Raanan Arens, MD | Montefiore Children's Hospital Albert Einstein Med Ctr, NY NY |
| Principal Investigator: | Hiren Muzumdar, MD | Montefiore Chilren's Hospital Albert Einstein Med Ctr, NY NY |
| Principal Investigator: | Eliot Katz, MD | Boston Children's Hospital, Boston MA |
More Information
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00560859 History of Changes |
| Other Study ID Numbers: | 804695, 5U01HL083129-05 |
| Study First Received: | November 19, 2007 |
| Last Updated: | November 14, 2011 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
Sleep disordered breathing Sleep apnea Tonsillectomy Adenoidectomy |
Snoring Neurobehavioral Manifestations Obstructive Sleep Apnea Syndrome |
|
Apnea Sleep Apnea Syndromes Snoring Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Respiratory Sounds |