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

NCT06738589 | Not Yet Recruiting

• 1 other identifier: U1111-1315-8696
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Soft Palate; MRI; NIV; Airway

Outcome Measures

Primary Outcomes (1)

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

  millimeters cubed

  Single 2 hour visit

Secondary Outcomes (2)

• Impact of positive pressure ventilation on airway volume in millimeters cubed,

  Single 2 hour visit

• Upper airway resistance measurements

  Single 2 hour visit

Study Arms (2)

MRI without positive pressure therapy

NO INTERVENTION

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

MRI with positive pressure

EXPERIMENTAL

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

Device: non-invasive ventilation

Interventions

non-invasive ventilation DEVICE

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

MRI with positive pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged 18+
• Willing and able to consent to the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead
• The University of Auckland: collaborator

Study Sites (1)

University of Auckland

Auckland, New Zealand

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Alys Clark

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Miller

CONTACT

+64273032944; jamie.miller@fphcare.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 17, 2024
• Study Start: March 25, 2025
• Primary Completion: January 25, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

NZ (1)