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

Fisher & Paykel Healthcare

Status: Not yet enrolling

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

Treatments: Device: non-invasive ventilation

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06738589

U1111-1315-8696

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

MRI without positive pressure therapy

No Intervention group

Description:

Healthy volunteers having their upper airway scanned with MRI without the addition of positive airway pressure therapy (NIV)

MRI with positive pressure

Experimental group

Description:

Healthy volunteers having their upper airway scanned with MRI with the addition of positive airway pressure therapy (NIV)

Treatment:

Device: non-invasive ventilation