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Not yet recruiting Not applicable NCT06738589

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

No applicable phase (e.g. observational)
Conditions: Focus of the Study is the Anatomy of the Soft Palate Non-invasive Ventilation

Sponsor: Fisher and Paykel Healthcare

trial.available_in: БГ
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
Who can participate
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)
Locations 1
New Zealand (1)
University of Auckland
Auckland
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
25.03.2025
Completion date
01.08.2027
Registry ID
NCT06738589
Source
anzctr
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