Trial Information

Summary: Mechanisms Mediating Cardiovascular Disease in Children with Obstructive Sleep Apnea

What is the purpose of this study?

The purpose is to study the way the body controls blood pressure in children with obstructive sleep apnea compared to children without sleep apnea.

Who can participate?

• Children ages 6-13 who have symptoms of obstruction during sleep such as snoring and have not had a tonsillectomy or adenoidectomy
• Children ages 6-13 who have no symptoms of obstruction during sleep and may have had a tonsillectomy or adenoidectomy more than two years previous to beginning the study

What is involved?

This study lasts for approximately one year and includes 4 visits, after an initial screening visit. The following is a list of procedures that will take place during the study:

• History and Physical
• Echocardiogram
• A 4:00 p.m. and 8:00 p.m. breathing and blood pressure study
• An overnight sleep study
• Also, there will be a 24-hour ambulatory blood pressure study that will be done at home

What are the benefits?

You will get information about your child’s sleep and blood pressure. The biggest benefit is that your child is helping other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools. Your child may receive no direct benefit from participating in this study.

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 are no risks other than minor discomfort from the blood pressure cuff and sleeping in the sleep lab. We do not give any medications or do any blood tests for this study.

What is the compensation?

There will be compensation at the end of each of the four visits with a total for completion of the entire study of $350.00.

Useful Links:

www.sleepnet.com
www.sleep-solutions.com/cons/Apnea_News/ap/kids_snoring.htm

For more information:

If you would like to learn more about participating in this study, please send an e-mail message using the form below.