Focus of the Study is the Anatomy of the Soft PalateNCT06738589
The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway
A study testing non-invasive ventilation in people with Focus of the Study is the Anatomy of the Soft Palate and Non-invasive Ventilation, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is the Anatomy of the Soft Palate, Non-invasive Ventilation
- What is being tested?
- non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNew Zealand
- Study dates
- 25 Mar 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 18+
- Willing and able to consent to the study
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site
University of Auckland
Auckland
Alys Clark, +6493737599 ext. 85604, alys.clark@auckland.ac.nz
About this study
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.
Read more
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
- Being tested
- non-invasive ventilation
- Keywords
- Soft Palate, MRI, NIV, Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilationDevice
Non-invasive ventilation adds positive pressure to the upper airway via a mask on the face.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric change of soft palate airway size in delta millimeters cubed,
millimeters cubed
Measured: Single 2 hour visit
Secondary outcomes (2)
Impact of positive pressure ventilation on airway volume in millimeters cubed,
Change in soft palate airway size with addition of positive pressure ventilation, measured from segmented MRI data of soft palatal airway, and expressed in millimeters cubed, and delta millimeters cubed
Measured: Single 2 hour visit
Upper airway resistance measurements
Changes in upper airway resistance based on different body positions, measured using anterior rhinomanometry according to international guidelines and resistance units expressed as Pa/cm3/s
Measured: Single 2 hour visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start25 Mar 2025 (estimated)
- Primary completion25 Jan 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study is the Anatomy of the Soft PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Auckland
- Responsible party
- Sponsor
- Investigators
- Alys Clark, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738589
- Sponsor's protocol ID
- U1111-1315-8696
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified and anonymized study data may be shared for further statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway
- ClinicalTrials.gov ID
- NCT06738589
- Acronym / sponsor ID
- U1111-1315-8696
- Keywords
- Soft Palate, MRI, NIV, Airway
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- The University of Auckland
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 25 Jan 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: non-invasive ventilationHealthy volunteers having their upper airway scanned with MRI with the addition of positive airway pressure therapy (NIV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults aged 18+
- Willing and able to consent to the study
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive ventilationNon-invasive ventilation adds positive pressure to the upper airway via a mask on the face. | Device | MRI with positive pressure |
Primary outcome
Volumetric change of soft palate airway size in delta millimeters cubed,
Time frame: Single 2 hour visit
millimeters cubed
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided. De-identified and anonymized study data may be shared for further statistical analysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alys Clark principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive ventilation in people with Focus of the Study is the Anatomy of the Soft Palate and Non-invasive Ventilation, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Miller (+64273032944, jamie.miller@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric change of soft palate airway size in delta millimeters cubed, (time frame: Single 2 hour visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.