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NCT06258837 · ClinicalTrials.gov registry record · NA
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
A NA study of Obstructive Sleep Apnea and Otolaryngological Disease, sponsored by Oregon Health and Science University.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 2
- Study locations
NCT06258837: Recruiting NA study of Obstructive Sleep Apnea and Otolaryngological Disease, sponsored by Oregon Health and Science University.
NCT06258837 is a NA study of Obstructive Sleep Apnea and Otolaryngological Disease that is actively recruiting participants, run by Oregon Health and Science University. The registered enrollment target is 240 participants, roughly in line with the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06258837, a NA study of Obstructive Sleep Apnea and Otolaryngological Disease, is actively recruiting participants, sponsored by Oregon Health and Science University.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (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 ST will perform better than 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 propose to study children aged 2-17 years with small tonsils and OSA.
Primary Outcome
Objective results from sleep studies (polysomnography): Obstructive Apnea-Hypopnea Index (oAHI): 6 months follow up sleep study difference from baseline sleep study. Higher scores indicate higher disease burden. Scores can range from zero to two hundred.
Conditions Studied
Interventions
- PROCEDURE DISE-Directed Surgery
- PROCEDURE Adenotonsillectomy
Study Locations (2)
Michigan
- University of Michigan - Ann Arbor
Oregon
- Oregon Health and Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-10-04 |
| Est. Completion | 2028-09-30 |
| Phase | NA |
What NCT06258837 shows while recruiting
NCT06258837 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target.
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which DISE-Directed Surgery is the first listed.
NCT06258837 reports a single indexed study location in Michigan, Oregon.
Frequently Asked Questions
What is clinical trial NCT06258837 about?
NCT06258837 is a clinical study titled "Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils". The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months. It is th...
What is the current status of trial NCT06258837?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2024-10-04. Estimated completion is 2028-09-30.
What conditions does trial NCT06258837 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Otolaryngological Disease.
What interventions are being tested in trial NCT06258837?
The interventions under investigation include: DISE-Directed Surgery (PROCEDURE), Adenotonsillectomy (PROCEDURE).
Who is sponsoring clinical trial NCT06258837?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06258837 being conducted?
This trial has 2 study locations across Michigan, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obstructive Sleep Apnea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06258837's enrollment target sits among peer trials
240 32nd of 155 higher than 123 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea 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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