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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06738589
• Lead Sponsor: Fisher and Paykel Healthcare

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Study Start: 2025-03-25
• Primary Completion: 2026-01-25
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy adults aged 18+
• Willing and able to consent to the study

Exclusion Criteria

• Contraindications for MRI (such as metal implants)
• Contraindications for NIV (such as pneumothorax)
• No history of lung or upper airway disease
• Claustrophobia
• Symptoms of a cold, flu, or significant congestion, within the last 3 days
• Self-reported confirmed or suspected pregnancy
• Palatal abnormalities or previous upper airway surgery (such as cleft palate and/or UPPP)
• Prior major head or neck surgery with or without irradiation (such as radiotherapy of cutaneous cancers, robotic surgery for an oropharyngeal cancer)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Volumetric change of soft palate airway size in delta millimeters cubed,	Single 2 hour visit	millimeters cubed

Secondary Outcome Measures

Name	Time	Method
Impact of positive pressure ventilation on airway volume in millimeters cubed,	Single 2 hour visit	Change in soft palate airway size with addition of positive pressure ventilation, measured from segmented MRI data of soft palatal airway, and expressed in millimeters cubed, and delta millimeters cubed
Upper airway resistance measurements	Single 2 hour visit	Changes in upper airway resistance based on different body positions, measured using anterior rhinomanometry according to international guidelines and resistance units expressed as Pa/cm3/s

Trial Locations

Locations (1)

University of Auckland; 🇳🇿 Auckland, New Zealand