CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 113 enrolled
Drug / intervention
Adenotonsillectomy +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/NCT01539278
NCT01539278N/ACompleted

Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea

Eastern Virginia Medical School·interventional·Posted Feb 27, 2012·Updated Aug 5, 2015

In Brief

A clinical study evaluating Adenotonsillectomy and Observation alone / no intervention for Sleep Apnea, Obstructive. Completed, enrolled 113 participants across 1 site.

Detailed Summary

In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure the majority of children. However, for children with only a mild degree of OSA and few symptoms, surgery is less clear-cut, since two-thirds of these children do not develop worsening disease. Research shows that some children with mild OSA and behavior problems are helped by removing the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores on tests that measure quality of life (QOL). The investigators hypothesize that children with mild OSA will demonstrate changes on QOL assessment following adenotonsillectomy. These findings may help to guide the surgeon in selecting the children with mild OSA who are more likely to benefit from surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2012
Enrollment StartFeb 1, 2011
Primary CompletionSep 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.3 years ago

Interventions

Adenotonsillectomyprocedure

Tonsils and adenoids are surgically removed

Observation alone / no interventionother

Patients are observed over time, no surgery is done, subjects complete QOL questionnaires at set intervals