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NCT Number: NCT06738589

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-invasive ventilation

Device

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

Primary outcomes

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

    Time frame: Single 2 hour visit

    millimeters cubed

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie Miller

CONTACT

[email protected]

+64273032944

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Collaborators

  • The University of Auckland

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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