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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 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.

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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.

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

FieldValue
Enrollment Target 240 participants
Start Date 2024-10-04
Est. Completion 2028-09-30
Phase NA

What the Registry Record Tells You About NCT06258837

The ClinicalTrials.gov registry entry for NCT06258837 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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