The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: non-invasive ventilation.
- Who it may be relevant to
- Registry conditions: Focus of the Study is the Anatomy of the Soft Palate, Non-invasive Ventilation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device non-invasive ventilation
Non-invasive ventilation adds positive pressure to the upper airway via a mask on the face.
Primary outcome measures
- Volumetric change of soft palate airway size in delta millimeters cubed, [Time frame: Single 2 hour visit]
Secondary outcome measures (2)
- Impact of positive pressure ventilation on airway volume in millimeters cubed, [Time frame: Single 2 hour visit]
- Upper airway resistance measurements [Time frame: Single 2 hour visit]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
New Zealand · 1 center
- University of Auckland — Auckland
Identifiers
NCT: NCT06738589 · U1111-1315-8696