Clinical Trial

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

Not Yet Recruiting
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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.
Summary
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-16.
Trial Details
NCT Number NCT06738589
Lead Sponsor Fisher and Paykel Healthcare
Collaborators: The University of Auckland
Conditions Focus of the Study is the Anatomy of the Soft Palate, Non-invasive Ventilation
Enrollment 50 participants
Start Date 2025-03-25
Primary Completion 2026-01-25 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-05