The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers

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.

NCT Number	NCT07463716
Lead Sponsor	Fisher and Paykel Healthcare
Conditions	Healthy Volunteers
Enrollment	10 participants
Start Date	2026-03
Primary Completion	2026-05 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-11