DISE: Phenotyping Obstruction Patterns

Study acronym: DISE-PhOP
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 8 months later Sep 2026 → Jun 2027
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary completion pushed from Sep 2026 to Jun 2027 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment closed, study ongoing
    • Study completion pushed from Sep 2027 to Dec 2027
    • Interventions modified
    • Secondary endpoints: 4 to 3
    • Site details revised
    • Eligibility criteria shortened, about 3 words
    • Study description shortened, about 4 words
  2. Site contact updatedv7
  3. Re-verified, no change to tracked fieldsv6
  4. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 80 to 241
    • Site details revised
    v5
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 528 to confirmed 80
    • Eligibility criteria expanded, about 25 words
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Oct 11, 2021 to Nov 12, 2021v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2021 to Oct 11, 2021
    • Study description revised
    v2
  1. Study First Submitted
  • 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.
Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction. The investigators will apply nasal pressure (CPAP) during DISE to generate pressure-flow relationships, deriving functional determinants of upper airway obstruction during sleep. In addition, they will use objective anatomic measurements from computerized tomography (CT) and submental ultrasound. The findings will allow the investigators to streamline the upper airway exam during DISE, and will further the goal of developing personalized solutions that address specific pathogenic mechanisms of pharyngeal collapse and airflow obstruction during sleep. The investigators will use the physiologic and anatomic features derived from DISE and imaging to determine which are predictive of success to standard-of-care surgical interventions (e.g. skeletal, soft tissue, neurostimulation) .
Trial Details
NCT Number NCT05050383
Lead Sponsor University of Pennsylvania
Conditions
(from sponsor)		 Obstructive Sleep Apnea
Related terms Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Snoring
Enrollment 241 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov