Childhood Adenotonsillectomy Study for Children With OSAS (CHAT)
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|ClinicalTrials.gov Identifier: NCT00560859|
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Snoring||Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils Other: Watchful Waiting||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||453 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||June 2012|
Active Comparator: Early AT Surgery
There will be removal of tonsils and adenoids that will be performed 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 which includes removal of adenoids and tonsils
Other Name: EAT
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)
- Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months. [ Time Frame: The primary endpoint measure will occur at 7 months following the baseline visit. ]The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.
- Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months [ Time Frame: 7 months following the baseline visit. ]The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.
- Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale [ Time Frame: 7 months following baseline. ]Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560859
|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|
|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|