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

Fisher and Paykel Healthcare1 site in 1 country50 target enrollmentMarch 25, 2025

ConditionsFocus of the Study is the Anatomy of the Soft Palate Non-invasive Ventilation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Focus of the Study is the Anatomy of the Soft Palate
Sponsor: Fisher and Paykel Healthcare
Enrollment: 50
Locations: 1
Primary Endpoint: Volumetric change of soft palate airway size in delta millimeters cubed,
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 25, 2025

End Date

August 1, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Fisher and Paykel Healthcare

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Volumetric change of soft palate airway size in delta millimeters cubed,

Time Frame: Single 2 hour visit

millimeters cubed

Secondary Outcomes

Impact of positive pressure ventilation on airway volume in millimeters cubed,(Single 2 hour visit)
Upper airway resistance measurements(Single 2 hour visit)