Seeking Participants in Pediatric Adenotonsillectomy Trial for Snoring (PATS)
March 22, 2018
Pediatric Clinical Update - March 2018
UH Rainbow Babies & Children’s Hospital Sleep Center is seeking participants for the Pediatric Adenotonsillectomy Trial for Snoring (PATS), a research study looking at the best care for children who have snoring and breathing problems during sleep, but who do not have apnea. This problem is called mild sleep disordered breathing (MSDB). It is not yet known whether MSDB is associated with behavior or other health problems in children.
A common treatment for MSDB is removal of the tonsils and adenoids, but this has not been well studied. This study will help researchers learn what the best treatment is for children with MSDB.
Advantages for participating families include:
- Find out if the child has MSDB
- Learn about sleep disorders and treatments for MSDB
- Have the child monitored for behavior and health concerns that may be associated with MSDB
- Comprehensive monitoring of the child for 12 months; monitoring includes sleep studies, growth measurements, lab work, blood pressure and behavior
- Help researchers learn more about MSDB and how they can help these children
Children are eligible for the study if they are between the ages of 3 and 12 yrs. with snoring during sleep, have not been diagnosed with obstructive sleep apnea and have not had their tonsils removed.
Children in the study will be placed in one of two groups including (1) early removal of tonsils and adenoids about 1 month after sleep study and (2) watchful waiting with supportive care for 12 months.
Participation will include two overnight sleep studies and three daytime visits that include behavioral testing, blood pressure measurements, body measurements, parent questionnaires and blood and urine test (during visit one only). Families will also participate in monthly telephone calls and Actigraphy: A wristwatch-like device for the child to wear at home for seven days that measures your child’s wake and sleep at home. There will also be teacher questionnaires, as part of the study.
Families will be compensated for time and travel. Patients will receive education from our Rainbow sleep medicine experts. Participation is voluntary and families are free to withdraw at any time.
If you have patients who you feel would benefit from participation, please have them call Heather Rogers, RPSGT, Study Coordinator at 216-368-0475.
Carol Rosen, MD and Kristie Ross, MD, co-principal investigators for the PATS trial, can be reached at 216-844-3267. The trial is sponsored by the National Heart, Lung, and Blood Institutes of Health.
Tags: Clinical Research