NCT06738589

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Focus of the Study is the Anatomy of the Soft Palate
• Non-invasive Ventilation

Interventions

Type	Name	Description
DEVICE	non-invasive ventilation	Non-invasive ventilation adds positive pressure to the upper airway via a mask on the face.

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-01-25
• Completion: 2027-08-01
• First posted: 2024-12-17
• Last updated: 2025-03-05

Locations

1 site across 1 country: New Zealand