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NCT05154214 · ClinicalTrials.gov registry record
Surgical Treatment of Children With OSA and Small Tonsils or Down Syndrome
A clinical trial, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- 30
- Enrollment target
NCT05154214: Completed study, sponsored by Oregon Health and Science University.
NCT05154214 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05154214 has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to prospectively compare the effectiveness of a novel personalized approach to the surgical treatment of obstructive sleep apnea (OSA) in children, drug induced sleep endoscopy (DISE) directed surgery versus the standard adenotonsillectomy (AT). This will also serve to test the feasibility of recruiting families for a future randomized protocol comparing the same surgical techniques. It is the investigators' central hypothesis that a personalized DISE-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with small tonsils or Down syndrome will be superior to the currently recommended standard first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT. To test this hypothesis, the investigators will study children aged 2 to 18 years with clinically small tonsils (Brodsky score 1+ or 2+ on a scale 1+ to 4+) OR Down syndrome.
Primary Outcome
Parent and child-reported surveys, higher scores indicate better quality of life, mean scores 0-100
Interventions
- PROCEDURE Adenotonsillectomy
- PROCEDURE Drug-induced sleep endoscopy directed surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2024-10-11 |
What the finished NCT05154214 record still lists
NCT05154214 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Adenotonsillectomy is the first listed.
NCT05154214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05154214 about?
NCT05154214 is a clinical study titled "Surgical Treatment of Children With OSA and Small Tonsils or Down Syndrome". The purpose of this study is to prospectively compare the effectiveness of a novel personalized approach to the surgical treatment of obstructive sleep apnea (OSA) in children, drug induced sleep endoscopy (DISE) directed surgery versus the standard adenotonsillectomy (AT). This will also serve to t...
What is the current status of trial NCT05154214?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2021-11-09. Estimated completion is 2024-10-11.
What interventions are being tested in trial NCT05154214?
The interventions under investigation include: Adenotonsillectomy (PROCEDURE), Drug-induced sleep endoscopy directed surgery (PROCEDURE).
Who is sponsoring clinical trial NCT05154214?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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