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

Starting soon · Not applicable

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT07463716

Run by

Fisher and Paykel Healthcare

People needed

10

Starts

2026-03-01

Expected to finish

2026-06-01

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 18 years or over
• Able to give informed consent

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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