Pediatric Adenotonsillectomy Trial for Snoring

Summary

The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.

Conditions

• Sleep-Disordered Breathing

Interventions

PROCEDURE

Early Adenotonsillectomy (eAT)

Standard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.

BEHAVIORAL

Watchful Waiting with Supportive Care (WWSC)

Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Children's Hospital of The King's Daughters

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Susan S Redline, MD, MPH · Brigham and Women's Hospital

• Rui Wang, PhD · Brigham and Women's Hospital

• Susan L. Furth, MD, PhD · Children's Hospital of Philadelphia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-06

Primary Completion

2022-02-21

Completion

2022-02-28

Countries

• United States

Study Locations