MedTrace Logo

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

NCT06738589 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-05

No results posted yet for this study

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

DEVICE

non-invasive ventilation

Non-invasive ventilation adds positive pressure to the upper airway via a mask on the face.

Sponsors & Collaborators

  • The University of Auckland

    collaborator UNKNOWN

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • Alys Clark · University of Auckland, New Zealand

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-01-25
Completion
2027-08-01

Countries

  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06738589 on ClinicalTrials.gov