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

NCT01539278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2015-08-05

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

PROCEDURE

Adenotonsillectomy

Tonsils and adenoids are surgically removed

OTHER

Observation alone / no intervention

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

Sponsors & Collaborators

  • Children's Hospital of The King's Daughters

    collaborator OTHER

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Cristina M. Baldassari, MD · Eastern Virginia Medical School Dept. of Otolaryngology-Head & Neck Surgery; Children's Hospital of the King's Daughters

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539278 on ClinicalTrials.gov