Sleep Apnea Study for Children 5 to 13 with Enlarged Tonsils
What is the purpose of this study?
The goal of this study is to understand the effects that sleep apnea have on the blood vessel system, blood pressure and the heart.
Who can participate?
Children ages 5 to13 with snoring and suspected sleep apnea who are planning on having surgery to remove their tonsils may be eligible to participate.
Ages
Conditions
- Ear Nose and Throat (ENT)
- Sleep
What is involved?
This study lasts for 18 months and includes 3 visits. The following is a list of procedures that will take place during the study:
- Ultrasound – a picture of heart
- Overnight sleep studies (Parents spend the night with the children)
- Blood pressure monitoring
- Blood draw
What are the benefits?
Through your participation in this study, you may:
- Gain an understanding of your child’s sleep, blood pressure and heart
- Learn about earlier recognition and prevention of circulatory problems and heart changes that may result from obstructive sleep apnea
- Obtain an understanding of how the body reverses these changes with treatment
Your child may receive no direct benefit from participating in this study. The biggest benefit is that your child may be helping other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
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.
Do participants receive pay, compensation or reimbursement?
Participants will receive a total compensation of $500 for completing all portions of the study.
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
