Sleep Apnea Study for Children 5 to 9 with Enlarged Tonsils
CHAT (Children’s Adenotonsillectomy Study)
(This study is looking at learning and general health)
What is the purpose of this study?
This is an obstructive sleep apnea research study looking at the best care for children who snore and have enlarged tonsils and adenoids. We are looking at the connection that sleep apnea has to:
- Learning and ADHD (Attention Deficit Hyperactivity Disorder) problems
- Pre-diabetes
- High cholesterol
- Slow growth and obesity
Who will be included in this study?
- Healthy children ages 5 to 9 years old
- Children with large tonsils and adenoids
- Children who snore or pause while they breathe during sleep
- Children who have been told by their doctor that they may benefit from having their tonsils and adenoids removed
What is involved?
This study lasts for 12 months and includes 7 visits. The following is a list of procedures that will take place during the study:
- Overnight sleep studies (Parents spend the night with the children)
- Learning and behavioral tests
- Two blood draws (numbing cream used)
- Blood pressure monitoring
- Measurements of height and weight
- Educational material regarding healthy sleep habits and nutrition
- Results of the learning tests will be given to share with your child’s school at the end of the second testing visit.
What are the benefits?
You can learn more about obstructive sleep apnea syndrome and healthy sleep habits. You will learn if your child has risk factors for high cholesterol or blood sugar. By volunteering, you can help us to better understand the connection between sleep, health and learning.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
There is the risk of bruising at the site of the blood draw. Also, there may be temporary skin redness in the area where the stickers are attached from study equipment that watches the heart beat and measure your child’s sleep.
What is the pay?
Participants will receive $500 for their time and travel, if all procedures and visits are completed.
Who should I contact for more information?
Belinda E. Carter
Cincinnati Children’s Hospital Medical Center
Pulmonary Medicine – MLC 2021
3333 Burnet Ave., Cincinnati, OH 45229-2021
Phone: 513-636-2814
belinda.carter@cchmc.org
