Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Primary Endpoint
- Number of participants with average system leak >60L/min
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of participants with average system leak >60L/min
Time Frame: Two weeks in-home use
Average system leak will be recorded through downloading of the data from the PAP device in L/min.
Secondary Outcomes
- Number of participants that found the mask comfortable.(Two weeks in-home use)
- Insights into mask fitting and removal.(Two weeks use)