The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers (NCT07463716) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers
10 participantsStarted 2026-03
Plain-language 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.
* 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or over
* Able to give informed consent
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.