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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06738589




Registration number
NCT06738589
Ethics application status
Date submitted
2/12/2024
Date registered
17/12/2024

Titles & IDs
Public title
The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway
Scientific title
The Inflate Study; Defining the Soft Palate in the Upper Airway Flow Pathway
Secondary ID [1] 0 0
U1111-1315-8696
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focus of the Study is the Anatomy of the Soft Palate 0 0
Non-invasive Ventilation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - non-invasive ventilation

No intervention: MRI without positive pressure therapy - Healthy volunteers having their upper airway scanned with MRI without the addition of positive airway pressure therapy (NIV)

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


Treatment: Devices: non-invasive ventilation
Non-invasive ventilation adds positive pressure to the upper airway via a mask on the face.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Volumetric change of soft palate airway size in delta millimeters cubed,
Timepoint [1] 0 0
Single 2 hour visit
Secondary outcome [1] 0 0
Impact of positive pressure ventilation on airway volume in millimeters cubed,
Timepoint [1] 0 0
Single 2 hour visit
Secondary outcome [2] 0 0
Upper airway resistance measurements
Timepoint [2] 0 0
Single 2 hour visit

Eligibility
Key inclusion criteria
* Healthy adults aged 18+
* Willing and able to consent to the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
25/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fisher and Paykel Healthcare
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Auckland
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alys Clark
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jamie Miller
Address 0 0
Country 0 0
Phone 0 0
+64273032944
Fax 0 0
Email 0 0
jamie.miller@fphcare.co.nz
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
De-identified and anonymized study data may be shared for further statistical analysis


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06738589