Childhood Adenotonsillectomy Study for Children With OSAS

Summary

The purpose of this research is to determine the effect of adenotonsillectomy surgery (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children. OSAS can cause health problems including poor growth, high blood pressure, diabetes and behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve afterwards. This study will help determine if improvement occurs or if it does not. It will also look at whether certain groups, such as children who are overweight or of different ethnicities, are helped by the surgery.

Conditions

• Obstructive Sleep Apnea
• Snoring

Interventions

PROCEDURE

Adenotonsillectomy (AT) - removal of adenoids and tonsils

Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils

OTHER

Watchful Waiting

Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Sponsors & Collaborators

• Harvard University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Susan Redline, MD, MPH · Harvard University

• Susan Ellenberg, Ph.D. · University of Pennsylvania

• Ron Chervin, MD, MS · University of Michigan

• Bruno Giordani, PH.D. · Univeristy of Michigan

• Susan Garetz, MD · University of Michigan

• Raouf Amin, MD · Cincinnati Children's Hopsital Medical Center (CCHMC)

• Carole Marcus, MBB Ch. · Children's Hospital of Philadelphia

• Carol Rosen, MD · Case University School of Medicine; Rainbow Babies & Children's Hospital

• Ron Mitchell, MD · Cardinal Glennon Children's Medical Center, St. Louis MO

• Raanan Arens, MD · Montefiore Children's Hospital Albert Einstein Med Ctr, NY NY

• Hiren Muzumdar, MD · Montefiore Chilren's Hospital Albert Einstein Med Ctr, NY NY

• Eliot Katz, MD · Boston Children's Hospital, Boston MA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2012-03-31

Completion

2012-06-30

Countries

• United States

Study Locations