CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 459 enrolled
Drug / intervention
Early Adenotonsillectomy (eAT) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02562040
NCT02562040N/ACompleted

Impact of Treatment of Mild Sleep-Disordered Breathing on Children's Health

Brigham and Women's Hospital·interventional·Posted Sep 29, 2015·Updated Nov 15, 2024

In Brief

A clinical study evaluating Early Adenotonsillectomy (eAT) and Watchful Waiting with Supportive Care (WWSC) for Sleep-Disordered Breathing. Completed, enrolled 459 participants across 7 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 29, 2015
Enrollment StartJun 6, 2017
Primary CompletionFeb 21, 2022
Study CompletionFeb 28, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.8 years ago

Interventions

Early Adenotonsillectomy (eAT)procedure

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.

Watchful Waiting with Supportive Care (WWSC)behavioral

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