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Computer Models of Airways in Children and Young Adults With Sleep Apnea and Down Syndrome

Study acronym: DYMOSA
StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Children's Hospital Medical Center, Cincinnati to Children's Hospital Medical Center, Cincinnati Trial status changed: Enrolling by Invitation → Completed · Final enrollment: 81 participants (planned 73) · Primary completion date changed from estimate of Dec 2028 to Feb 26, 2026 · 5 more Show 8 more changesShow less
    • Trial status changed: Enrolling by Invitation → Completed
    • Final enrollment: 81 participants (planned 73)
    • Primary completion date changed from estimate of Dec 2028 to Feb 26, 2026
    • Start date: Mar 2011 to Mar 1, 2011
    • Eligibility criteria expanded, about 6 words
    • Study description revised
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Dec 2027 to Dec 2028v14
  3. 5 versions Re-verified since Jul 9, 2019, no change to tracked fieldsv9-v13
  4. Primary completion date: Dec 2018 to Dec 2027 Trial status: Recruiting to Enrolling by Invitation · Completion date: Dec 2019 to Dec 2027 · Site details revised · 1 morev8 Show 4 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Completion date: Dec 2019 to Dec 2027
    • Site details revised
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Nov 2016 to Dec 2018 · Enrollment target: 57 to 73 · Completion date: Nov 2016 to Dec 2019 · 1 morev7 Show 4 more changesShow less
    • Primary completion date: Nov 2016 to Dec 2018
    • Enrollment target: 57 to 73
    • Completion date: Nov 2016 to Dec 2019
    • Site details revised
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 73 to confirmed 57 · Primary completion date: Oct 2016 to Nov 2016 · Completion date: Aug 2017 to Nov 2016 · 1 morev6 Show 4 more changesShow less
    • Enrollment target: estimated 73 to confirmed 57
    • Primary completion date: Oct 2016 to Nov 2016
    • Completion date: Aug 2017 to Nov 2016
    • Site details revised
  2. Primary completion date: Nov 2015 to Oct 2016 Completion date: Aug 2016 to Aug 2017v5 Show 1 more changeShow less
    • Completion date: Aug 2016 to Aug 2017
  3. Completion date: Nov 2015 to Aug 2016v4
  4. Eligibility criteria expanded, about 6 wordsv3 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv2
  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 research study is to develop a way of predicting with computers how surgery on the airway will affect night time breathing called Obstructive Sleep Apnea (OSA) in children with Down Syndrome. A research measurement for airway resistance will also be done during the clinical sleep MRI. The airway resistance measurement will take about 10 minutes and is done during sleep. The airway resistance measurement is called critical closing pressure (Pcrit).
Trial Details
NCT Number NCT01902407
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Down Syndrome, Obstructive Sleep Apnea
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov