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NCT01539278 · ClinicalTrials.gov registry record · NA
Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
A NA study, sponsored by Eastern Virginia Medical School.
- Completed
- Registry status
- NA
- Development phase
- 113
- Enrollment target
NCT01539278: Completed NA study, sponsored by Eastern Virginia Medical School.
NCT01539278 is a NA study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 113 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01539278, a NA study, has completed, sponsored by Eastern Virginia Medical School.
- COMPLETED
- Registry status
- NA
- Development phase
- 113 participants
- Enrollment target
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.
Primary Outcome
HR-QOL forms OSA-18 and CHQ-28 to be completed by subjects at the time of enrollment, and at thereafter at three and six months. Main outcome measure is the difference or change from baseline.
Interventions
- PROCEDURE Adenotonsillectomy
- OTHER Observation alone / no intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-10 |
| Phase | NA |
What the finished NCT01539278 record still lists
NCT01539278 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Adenotonsillectomy is the first listed.
NCT01539278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01539278 about?
NCT01539278 is a clinical study titled "Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea". 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. H...
What is the current status of trial NCT01539278?
This trial is currently completed. It is a NA study. The enrollment target is 113 participants. The study started on 2011-02. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01539278?
The interventions under investigation include: Adenotonsillectomy (PROCEDURE), Observation alone / no intervention (OTHER).
Who is sponsoring clinical trial NCT01539278?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01539278's enrollment target sits among peer trials
113 813th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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