An interventional study of Non-invasive ventilation (NIV) in Healthy Volunteers, sponsored by Fisher and Paykel Healthcare. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment
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:
Participants will attend five study visits:
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:
Fisher and Paykel Healthcare is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mask A is the investigational mask
Device: Non-invasive ventilation (NIV)
Mask A is the investigational mask
Device: Non-invasive ventilation (NIV)
Mask B is a comparator mask
Device: Non-invasive ventilation (NIV)
Mask B is a comparator mask
Device: Non-invasive ventilation (NIV)
Mask C is a comparator mask
Device: Non-invasive ventilation (NIV)
Mask C is a comparator mask
Device: Non-invasive ventilation (NIV)
Mask D is a comparator mask
Device: Non-invasive ventilation (NIV)
Mask D is a comparator mask
Device: Non-invasive ventilation (NIV)
Delivery of positive airway pressure to the lungs via an interface, such as a mask
Change in ventilatory ratio
To assess if mask design can reduce ventilatory ration in healthy volunteers
Time frame: 15 minutes
Change in transcutaneous carbon dioxide (CO2)
To assess if mask design can reduce transcutaneous CO2 in healthy volunteers
Time frame: 15 minutes
Change in respiratory rate
To assess if mask design can reduce respiratory rate in healthy volunteers
Time frame: 15 minutes
Change in tidal volume
To assess if mask design can reduce tidal volume in healthy volunteers
Time frame: 15 minutes
No study locations are listed for this record.
Plan to share: No — All data to be deidentified
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for May 2026, 2 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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