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

NCT ID: NCT06738589

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2027-08-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

MRI without positive pressure therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

MRI with positive pressure

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

Group Type: EXPERIMENTAL

non-invasive ventilation

Intervention Type: DEVICE

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

Interventions

non-invasive ventilation

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Auckland

UNKNOWN

Sponsor Role: collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alys Clark

Role: PRINCIPAL_INVESTIGATOR

University of Auckland, New Zealand

Locations

University of Auckland

Auckland, , New Zealand

Countries

New Zealand

Central Contacts

Jamie Miller

Role: CONTACT

jamie.miller@fphcare.co.nz

+64273032944

Facility Contacts

Alys Clark

Role: primary

alys.clark@auckland.ac.nz

+6493737599 ext. 85604

Other Identifiers

U1111-1315-8696

Identifier Type: -

Identifier Source: org_study_id