Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to look at the effect of tonsil and adenoid surgery on children who have MSDB.
This study involves overnight sleep studies.
Who can participate?
Children 3 to 12 years old who:
- Have not been diagnosed with obstructive sleep apnea
- Have not had their tonsils and adenoid removed
What will happen in the study?
This study involves 5 study visits and monthly phone calls over 12 months.
- 2 overnight sleep studies
- 3 daytime study visits which will include:
- Behavioral testing
- Blood pressure monitoring
- Body measurements
- Blood and urine tests
- Parent questionnaires
- Monthly telephone calls
- Actigraphy, which involves wearing a wrist watch-like device at home for 7 days to measure your child wake and sleep times
- Teacher questionnaires
Participants will be randomly placed (put in a group by chance, like flipping a coin) in 1 of the following 2 groups:
- Group with early removal of tonsils and adenoid about 1 month after a sleep study
- Watchful waiting group with supportive care for 12 months and re-evaluation by the Ear, Nose and Throat (ENT) doctor for treatment at 12 months
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
Your child may not benefit from this study right now, as we do not know which treatment is better. If he/she has surgery, it is possible that he/she will have improvements in his behavior, sleepiness or quality of life. Also, it is possible that in the future, your child will be less likely to have high blood pressure.
If your child is in the watchful waiting group, it is possible that he/she will benefit by getting better on his/her own and not having to go through the surgery.
You may also find out whether your child has other health problems. Overall, the knowledge gained from this research study may help doctors learn more about MSDB and how they can help children with MSDB.