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

NCT07463716 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

Non-invasive ventilation (NIV)

Delivery of positive airway pressure to the lungs via an interface, such as a mask

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • William Good, Medical degree · Middlemore Hospital, New Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-05-31
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463716 on ClinicalTrials.gov