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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Non-invasive Ventilation; Focus of the Study is the Anatomy of the Soft Palate
• Intervention / Treatment: Device: non-invasive ventilation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie Miller; Phone Number: +64273032944; Email: jamie.miller@fphcare.co.nz

Study Locations

• New Zealand
  • Auckland, New Zealand
    • University of Auckland
    • Contact: Alys Clark; Phone Number: 85604 +6493737599; Email: alys.clark@auckland.ac.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: MRI without positive pressure therapy; Healthy volunteers having their upper airway scanned with MRI without the addition of positive airway pressure therapy (NIV)
Experimental: MRI with positive pressure; Healthy volunteers having their upper airway scanned with MRI with the addition of positive airway pressure therapy (NIV)	Device: non-invasive ventilation; Non-invasive ventilation adds positive pressure to the upper airway via a mask on the face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric change of soft palate airway size in delta millimeters cubed,	millimeters cubed	Single 2 hour visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of positive pressure ventilation on airway volume in millimeters cubed,	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	Single 2 hour visit
Upper airway resistance measurements	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	Single 2 hour visit

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Collaborators: The University of Auckland
• Investigators: Principal Investigator: Alys Clark, University of Auckland, New Zealand

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2025
• Primary Completion (Estimated): January 25, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: MRI; NIV; Airway; Soft Palate
• Other Study ID Numbers: U1111-1315-8696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified and anonymized study data may be shared for further statistical analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No