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About the Trial

The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a research study looking at treatment options for children who have snoring and mild breathing problems during sleep, but do not have sleep apnea (stopped breathing during sleep). This is called mild sleep disordered breathing (MSDB). MSDB is often treated with surgery to take out the tonsils and adenoids, and MSDB is also often observed or treated medically without surgery. 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. This study will help us learn more about the different treatment options for children with MSDB.

Read more on ClinicalTrials.gov.

Participate

Why you and your child may choose to participate:

  • Find out if your child has MSDB.
  • Learn about sleep disorders and treatments for MSDB.
  • Get your child evaluated for behavior and health problems that may be associated with MSDB.
  • Comprehensive monitoring of your child over the course of 12 months.
  • Monitoring includes sleep studies, growth measurements, lab work, blood pressure, behavior, and an evaluation by an Ear, Nose, and Throat (ENT) doctor.
  • Help doctors learn more about MSDB and how they can help these children.

Who may participate?

  • Children ages 3-12 years with snoring during sleep.
  • Children who have not been diagnosed with obstructive sleep apnea.
  • Children who have not had their tonsils and adenoid removed.

What is involved?

Children in the study will be randomly placed in one of two groups:

  • Early removal of tonsils and adenoid about 1 month after sleep study
  • Watchful Waiting with Supportive Care for 12 months. Re-evaluation by the Ear, Nose, and Throat (ENT) doctor for treatment at 12 months for those in the Watchful Waiting with Supportive Care group.

All children in the study will receive:

  • 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: A wrist watch-like device to wear at home for 7 days that measures your child's wake and sleep at home
  • Teacher questionnaires

Please keep in mind:

  • Participation is voluntary.
  • You are free to withdraw from this study at any time.
  • We encourage you to ask questions, and express all of your concerns.
  • Your child's health is important to us.
  • We will reimburse you for your time and expenses.

Sites

Recruiting Centers

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Laurie Karamessinis, 215-590-9184, karamessil@email.chop.edu

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Belinda Carter, 513-636-2814, belinda.carter@cchmc.org

University Hospitals-Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Heather Rogers, 216-368-0475, heather.rogers@uhhospitals.org

University of Michigan Health System

Ann Arbor, Michigan, United States, 48109

Sarah Brand, 734-232-4600, sabrand@med.umich.edu

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Constance Eshon, 214-456-5501, constance.eshon@childrens.com

Coordinating Centers

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Contact Us

Pediatric Adenotonsillectomy Trial for Snoring

our address

Sleep and Circadian Disorders
221 Longwood Avenue, BLI 225
Boston, MA 02115