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Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary and study completion dates: Jun 2030 to Jun 2035v24
  2. Re-verified, no change to tracked fieldsv23
  3. Trial status: Suspended to Recruiting
    • Site details revised
    v22
  4. Trial status: Recruiting to Suspended Sponsor's reason: Transfer to another institution
    • Lead sponsor: University of Southern California to University of California, Los Angeles
    • Study sites: 2 to 1
    v21
  5. 2 versions Re-verified since May 5, 2022, no change to tracked fieldsv19-v20
Show 17 earlier versionsHide 17 earlier versions
  1. Primary completion date: Jun 2020 to Jun 2030v18
  2. Study completion date: Jun 2020 to Jun 2030v17
  3. Re-verified, no change to tracked fieldsv16
  4. Site contacts updated at 2 of 2 sitesv15
  5. Re-verified, no change to tracked fieldsv14
  6. Enrollment target: 500 to 800v13
  7. Collaborators: 1 to 2v12
  8. Enrollment target: 300 to 500
    • Primary and study completion dates: Jun 2015 to Jun 2020
    v11
  9. Lead sponsor: University of California, San Francisco to University of Southern Californiav10 Show 4 more changesShow less
    • Study sites revised (2)
    • Collaborators expanded, about 15 words
    • Publications: 1 to 5
    • Study title shortened, about 1 word
  10. Primary completion date: Jun 2008 to Jun 2015v9
  11. 3 versions Re-verified since Jun 12, 2012, no change to tracked fieldsv6-v8
  12. Study sites: 1 to 2
    • Study completion date: Jun 2012 to Jun 2015
    • Study title expanded, about 1 word
    v5
  13. 3 versions Re-verified since Feb 17, 2009, no change to tracked fieldsv2-v4
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study has investigated the reliability of this technique, demonstrating moderate-substantial interrater and test-retest reliability. This research has also compared DISE findings to those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not responded to previous sleep apnea surgery. These papers have been published and available through PubMed. Additional research is ongoing, with examination of DISE findings, comparison to other evaluation techniques, and the association between DISE findings and surgical outcomes.
Trial Details
NCT Number NCT00695214
Lead Sponsor University of California, Los Angeles
Collaborators: National Institutes of Health (NIH), American Academy of Otolaryngology-Head and Neck Surgery Foundation
Conditions
(from sponsor)		 Sleep Apnea, Obstructive
Related terms Sleep Apnea, Obstructive
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov