Pediatric Sleep Center Conducts Leading-Edge Clinical Trials

In collaboration with Case Western Reserve University School of Medicine, the Pediatric Sleep Center at University Hospitals Rainbow Babies & Children’s Hospital conducts ongoing clinical trials around sleep disorders in children.

As a result, we have developed novel techniques and treatments for a broad range of sleep conditions. Our experts continue to seek the safest and most effective sleep treatments to improve the lives of children and establish national standards for clinic practice treatments.

Pediatric Adenotonsillectomy Trial for Snoring (PATS)

This research study is looking at the best care for children who have snoring and breathing problems during sleep, but do not have apnea (stopping breathing during sleep). 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. Your child’s ear, nose and throat (ENT) doctor can talk with you about whether your child is a good candidate for this study. This study will help us learn what the best treatment is for children with MSDB.

Parents may choose to enroll their child in the PATS study to:

• Confirm or rule out a diagnosis of MSDB
• Learn about sleep disorders and treatments for MSDB
• Have their child monitored for behavior and health concerns that may be associated with MSDB
• Help doctors learn more about MSDB and how they can help these children

Who is eligible for the PATS study?

• Children, ages 3 to 12 years, with snoring during sleep
• Children who have not been diagnosed with obstructive sleep apnea
• Children who have not had their tonsils removed

What is involved?

Children in the study will be randomly placed in one of two groups. One group will have their tonsils and adenoids removed approximately one month after their sleep study. The other group will not. Both groups will then be actively monitored for twelve months and provided with supportive care.

Monitoring includes:

• Sleep studies
• Growth measurements
• Lab work
• Blood pressure
• Behavioral components

All children in the study will have:

• Two overnight sleep studies
• Three daytime visits, which will include:
  • Behavioral testing
  • Blood pressure measurement
  • Body measurements
  • Parent questionnaires
  • Blood and urine test (during visit one only)
• Monthly telephone calls
• Actigraphy: A wristwatch-like device to wear at home for seven days that measures your child’s awake and sleep patterns at home
• Teacher questionnaires

Participation in the study is voluntary and you are free to withdraw from the study at any time. Your child’s health is important to us and we encourage you to ask questions and express all of your concerns. You will be reimbursed for your time and study-related expenses.

For more information, contact:

Study Coordinators

Hayley Groubert, RN, BSN
Clinical Research Nurse Specialist
216-844-7605

Erica Denallo
216-286-7453

Co-Principal Investigators

Carol Rosen, MD
Kristie Ross, MD
Sally Ibrahim, MD
216-844-3267

Sponsored by the National Heart, Lung, and Blood Institute, National Institutes of Health

The Childhood Adenotonsillectomy (CHAT) study

Sponsored by the National Institutes of Health (NIH), this study helps us to better understand the effects of removing tonsils and adenoids in the treatment of sleep apnea.

The Sickle Cell Anemia Sleep & Asthma Cohort Study (SAC)

This study examines the relationship between asthma, sleep and lung complications in children with sickle cell anemia.