Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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