Health TrialsbyHealthPanel

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

ConditionsFocus of the Study is the Anatomy of the Soft PalateNon-invasive Ventilation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFisher and Paykel Healthcare

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults aged 18+

Willing and able to consent to the study

Disqualifiers

Contraindications for MRI (such as metal implants)

Contraindications for NIV (such as pneumothorax)

No history of lung or upper airway disease

Claustrophobia

Trial design

Design model

Sequential

Treatments tested in this trial

  • non-invasive ventilation

    Device

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: MRI without positive pressure therapyNo intervention 0 interventions
Group B: MRI with positive pressureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

millimeters cubed

Time frame
Single 2 hour visit

Secondary outcomes

1

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

Time frame
Single 2 hour visit
2

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

Time frame
Single 2 hour visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fisher and Paykel Healthcare

Lead sponsor

The University of Auckland

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: