Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline

0mo left

Started Mar 2026

Shorter than P25 for not_applicable healthy-volunteers

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 months study duration

Study Progress90%

Mar 2026Jun 2026

Study Start

First participant enrolled

March 1, 2026

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed

9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 2, 2026

Last Update Submit

March 5, 2026

Conditions

Healthy Volunteers

Keywords

Noninvasive ventilationPulmonary

Outcome Measures

Primary Outcomes (1)

Change in ventilatory ratio
To assess if mask design can reduce ventilatory ration in healthy volunteers
15 minutes

Secondary Outcomes (3)

Change in transcutaneous carbon dioxide (CO2)
15 minutes
Change in respiratory rate
15 minutes
Change in tidal volume
15 minutes