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Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils

Study acronym: TOPS-ST
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 240 to 175v9
  2. Re-verified, no change to tracked fieldsv8
  3. Eligibility criteria expanded, about 12 wordsv7
  4. Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 1 to 2
    v6
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Oct 1, 2024 to Oct 4, 2024
    • Collaborators expanded, about 3 words
    v5
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  1. Start date: Jul 1, 2024 to Oct 1, 2024
    • Collaborators shortened, about 3 words
    v4
  2. Start date: Apr 1, 2024 to Jul 1, 2024v3
  3. Primary endpoints revised (7)
    • Study description expanded, about 6 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06258837
Lead Sponsor Oregon Health and Science University
Collaborators: University of Michigan
Conditions
(from sponsor)		 Otolaryngological Disease, Obstructive Sleep Apnea
Related terms Otorhinolaryngologic Diseases, Sleep Apnea, Obstructive
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov