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

March 3, 2025 updated by: Fisher and Paykel Healthcare

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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,
Time Frame: Single 2 hour visit
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,
Time Frame: 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
Single 2 hour visit
Upper airway resistance measurements
Time Frame: 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
Single 2 hour visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Collaborators

The University of Auckland

Investigators

  • Principal Investigator: Alys Clark, University of Auckland, New Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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