Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
Completed · Not applicable
Conditions studied: Sleep Apnea, Obstructive
In brief
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.
Key facts
- Study ID
- NCT01539278
- Run by
- Eastern Virginia Medical School
- People needed
- 113
- Starts
- 2011-02-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2015-08-05
Who can join
Age: 3 and older, up to 16. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Any obstructive breathing symptoms such as snoring, mouth-breathing, sleep pauses, gasping, restless sleep, witnessed apneas, daytime somnolence, and enuresis.
- Children between the ages of 3-16 years of age that have had a sleep study with an Apnea Hypopnea Index (AHI) score of 1 to 5.
You may not qualify if…
- Subject/LAR unwillingness to comply with all study procedures
- Prior otolaryngologic surgery
- Prior sleep study
- Pregnant or breastfeeding
- Under 3 years of age and older than 16 years of age
- Congenital head and neck malformations or other syndromes
Where it is running
- Children's Hospital of the King's Daughters — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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