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The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 5, 2025 (before its estimated January 25, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Start date: Jan 25, 2025 to Mar 25, 2025v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to understand the impact of the size and shape of the soft palate on gas airflow in the upper airway in healthy volunteers. Utilizing Magnetic Resonance Imaging (MRI), this study aims to investigate: * How does soft palate anatomy change in different body positions? * What is the impact of positive pressure therapy, in the form of non-invasive ventilation (NIV) on soft palate anatomy? Researchers will compare MRI data without positive pressure to with positive pressure imaging to see if the addition of positive pressure impacts the size and shape of the soft palate. Researchers will also utilize measures of upper airway resistance to assess the impact of soft palate anatomy of airflow dynamics. Participants will be asked to: * Lie inside an MRI scanner for up to 90 minutes (including breaks), in different body positions * Undergo NIV therapy for 5-10 minutes while breathing normally inside an MRI scanner * Have their upper airway resistance measured, in different body positions
Trial Details
NCT Number NCT06738589
Lead Sponsor Fisher and Paykel Healthcare
Collaborators: The University of Auckland
Conditions
(from sponsor)		 Focus of the Study is the Anatomy of the Soft Palate, Non-invasive Ventilation
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov