Healthy VolunteersNCT07463716
The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers
A study testing Non-invasive ventilation (NIV) in people with Healthy Volunteers, run by Fisher and Paykel Healthcare.
Trial summary
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts respiratory variables in healthy volunteers on NIV therapy. The main questions it aims to answer are: To assess if mask design impacts the ventilatory ratio in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Non-invasive ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jun 2026
- 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
- Aged 18 years or over
- Able to give informed consent
Who cannot join
- Unable to tolerate non-invasive ventilation (NIV)
- Unable to adequately fit an NIV mask
- Claustrophobia while using NIV
- Symptoms of cold or flu (including COVID-19) in previous twenty-four hours
- Chronic Rhinitis or self-reported history of upper airway obstruction
- Pneumothorax or history of previous pneumothorax
- Employee in the NIV team at Fisher \& Paykel Healthcare
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers: A Pilot Clinical Investigation
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts respiratory variables in healthy volunteers on NIV therapy. The main questions it aims to answer are:
- To assess if mask design impacts the ventilatory ratio in healthy volunteers.
- To assess if mask design impacts transcutaneous CO2, respiratory rate, and tidal volume in healthy volunteers.
Read more
Participants will attend five study visits:
- Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy.
- Visit 2. Participants will receive NIV with one of four masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV.
- Visits 3-5. Participants will receive NIV with one of the other three masks, repeating Visit 2.
Read the detailed description
The study compares breathing with four different NIV masks, the interventional mask and three conventional NIV masks. Participants will be monitored by transcutaneous carbon dioxide, heart rate, oxygen, and respiratory rate monitors.
Participants will attend five study visits:
- Visit 1. Participants will be fitted to use NIV briefly to acclimatize them to using the therapy and ensure the four study masks fit. Participants that fit the masks and tolerate NIV well will be invited to attend four further visits.
- Visit 2. Participants will be randomized as to which order they receive the masks, and which order they conduct mouth breathing and nose breathing. Baseline readings of normal unsupported breathing will be taken prior to going on NIV. Participants will the receive NIV with one of four masks for ten minutes and will be instructed to either breathe through their mouth or their nose. There will then be a break from NIV of at least ten minutes until baseline values of respiratory parameters have returned. Then there will be a second ten-minute period of NIV when the participant will be instructed to breathe through the other way through the nose or mouth. Once NIV therapy has been removed the participant will remain attached to the study monitoring equipment until respiratory parameters have returned to normal.
- Visits 3-5 are a repeat of Visit 2 with the other study masks. The study is then complete.
- Conditions
- Healthy Volunteers
- Being tested
- Non-invasive ventilation (NIV)
- Keywords
- Noninvasive ventilation, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilation (NIV)Device
Delivery of positive airway pressure to the lungs via an interface, such as a mask
| Study group | Role | What they receive |
|---|---|---|
| NIV using Mask A, with mouth-open | Experimental | Mask A is the investigational mask Receives: Device: Non-invasive ventilation (NIV) |
| NIV using Mask A, with mouth-closed | Experimental | Mask A is the investigational mask Receives: Device: Non-invasive ventilation (NIV) |
| NIV using Mask B, with mouth-open | Active comparator | Mask B is a comparator mask Receives: Device: Non-invasive ventilation (NIV) |
| NIV using Mask B, with mouth-closed | Active comparator | Mask B is a comparator mask Receives: Device: Non-invasive ventilation (NIV) |
| NIV using Mask C, with mouth-open | Active comparator | Mask C is a comparator mask Receives: Device: Non-invasive ventilation (NIV) |
| NIV using Mask C, with mouth-closed | Active comparator | Mask C is a comparator mask Receives: Device: Non-invasive ventilation (NIV) |
| NIV using Mask D, with mouth-open | Active comparator | Mask D is a comparator mask Receives: Device: Non-invasive ventilation (NIV) |
| NIV using Mask D, with mouth-closed | Active comparator | Mask D is a comparator mask Receives: Device: Non-invasive ventilation (NIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ventilatory ratio
To assess if mask design can reduce ventilatory ration in healthy volunteers
Measured: 15 minutes
Secondary outcomes (3)
Change in transcutaneous carbon dioxide (CO2)
To assess if mask design can reduce transcutaneous CO2 in healthy volunteers
Measured: 15 minutes
Change in respiratory rate
To assess if mask design can reduce respiratory rate in healthy volunteers
Measured: 15 minutes
Change in tidal volume
To assess if mask design can reduce tidal volume in healthy volunteers
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over, non-blinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Good, Medical degree, Principal investigator, Middlemore Hospital, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463716
- Sponsor's protocol ID
- CIA-366
- Other IDs
- U1111-1321-2331
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data to be deidentified
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers: A Pilot Clinical Investigation
- ClinicalTrials.gov ID
- NCT07463716
- Acronym / sponsor ID
- CIA-366
- Conditions
- Healthy Volunteers
- Keywords
- Noninvasive ventilation, Pulmonary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Mar 2026 (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 randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts respiratory variables in healthy volunteers on NIV therapy. The main questions it aims to answer are:
- To assess if mask design impacts the ventilatory ratio in healthy volunteers.
- To assess if mask design impacts transcutaneous CO2, respiratory rate, and tidal volume in healthy volunteers.
Participants will attend five study visits:
- Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy.
- Visit 2. Participants will receive NIV with one of four masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV.
- Visits 3-5. Participants will receive NIV with one of the other three masks, repeating Visit 2.
Detailed description
The study compares breathing with four different NIV masks, the interventional mask and three conventional NIV masks. Participants will be monitored by transcutaneous carbon dioxide, heart rate, oxygen, and respiratory rate monitors.
Participants will attend five study visits:
- Visit 1. Participants will be fitted to use NIV briefly to acclimatize them to using the therapy and ensure the four study masks fit. Participants that fit the masks and tolerate NIV well will be invited to attend four further visits.
- Visit 2. Participants will be randomized as to which order they receive the masks, and which order they conduct mouth breathing and nose breathing. Baseline readings of normal unsupported breathing will be taken prior to going on NIV. Participants will the receive NIV with one of four masks for ten minutes and will be instructed to either breathe through their mouth or their nose. There will then be a break from NIV of at least ten minutes until baseline values of respiratory parameters have returned. Then there will be a second ten-minute period of NIV when the participant will be instructed to breathe through the other way through the nose or mouth. Once NIV therapy has been removed the participant will remain attached to the study monitoring equipment until respiratory parameters have returned to normal.
- Visits 3-5 are a repeat of Visit 2 with the other study masks. The study is then complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
- Model description
- Randomized, cross-over, non-blinded
| Arm | Type | Receives |
|---|---|---|
| NIV using Mask A, with mouth-open | Experimental | Device: Non-invasive ventilation (NIV)Mask A is the investigational mask |
| NIV using Mask A, with mouth-closed | Experimental | Device: Non-invasive ventilation (NIV)Mask A is the investigational mask |
| NIV using Mask B, with mouth-open | Active comparator | Device: Non-invasive ventilation (NIV)Mask B is a comparator mask |
| NIV using Mask B, with mouth-closed | Active comparator | Device: Non-invasive ventilation (NIV)Mask B is a comparator mask |
| NIV using Mask C, with mouth-open | Active comparator | Device: Non-invasive ventilation (NIV)Mask C is a comparator mask |
| NIV using Mask C, with mouth-closed | Active comparator | Device: Non-invasive ventilation (NIV)Mask C is a comparator mask |
| NIV using Mask D, with mouth-open | Active comparator | Device: Non-invasive ventilation (NIV)Mask D is a comparator mask |
| NIV using Mask D, with mouth-closed | Active comparator | Device: Non-invasive ventilation (NIV)Mask D is a comparator mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or over
- Able to give informed consent
Key exclusion criteria (7 listed)
- Unable to tolerate non-invasive ventilation (NIV)
- Unable to adequately fit an NIV mask
- Claustrophobia while using NIV
- Symptoms of cold or flu (including COVID-19) in previous twenty-four hours
- Chronic Rhinitis or self-reported history of upper airway obstruction
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 ventilation (NIV)Delivery of positive airway pressure to the lungs via an interface, such as a mask | Device | NIV using Mask A, with mouth-closed, NIV using Mask A, with mouth-open, NIV using Mask B, with mouth-closed, NIV using Mask B, with mouth-open, NIV using Mask C, with mouth-closed, NIV using Mask C, with mouth-open, NIV using Mask D, with mouth-closed, NIV using Mask D, with mouth-open |
Primary outcome
Change in ventilatory ratio
Time frame: 15 minutes
To assess if mask design can reduce ventilatory ration in healthy volunteers
3 secondary outcomes
Change in transcutaneous carbon dioxide (CO2)
Time frame: 15 minutes
Change in respiratory rate
Time frame: 15 minutes
Change in tidal volume
Time frame: 15 minutes
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 11 Mar 2026.
- Individual participant dataSharing planned: No. All data to be deidentified
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Screening Protocol
Pain
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.
William Good, Medical degree principal investigator
Middlemore Hospital, New Zealand
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation (NIV) in people with Healthy Volunteers, run by Fisher and Paykel Healthcare.
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 7 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Olivia Kennington (+64(09)5740100 ext. 5425, olivia.kennington@fphcare.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ventilatory ratio (time frame: 15 minutes). 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 11 Mar 2026.