Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02540603

Enrollment

Registered

2015-09-04

Start date

2015-09-30

Completion date

2015-12-31

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.

Detailed description

A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. Participants will be on the trial for three weeks, using the prototypes at home for two weeks. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for one week prior to mask fitting with the full face trial mask.

Interventions

DEVICEF&P Jupiter Full Face Mask

Investigative F&P Jupiter full face mask to be used for OSA therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18+ years of age * Diagnosed with OSA by a practicing physician * Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)) * Existing full face users

Exclusion criteria

* Inability to give informed consent * Patients who are in a coma or decreased level of consciousness * Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture) * Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA) * Current diagnosis of CO2 retention * Pregnant or think they may be pregnant

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with average system leak >60L/min	Two weeks in-home use	Average system leak will be recorded through downloading of the data from the PAP device in L/min.

Secondary

Measure	Time frame	Description
Insights into mask fitting and removal.	Two weeks use	Observations of the action of fitting the mask and removing the mask will be noted.
Number of participants that found the mask comfortable.	Two weeks in-home use	Subjective feedback on comfort will be measured through questionnaires.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026