Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- The mask is comfortable and is effective for the participant during in-home use
Study Overview
Brief Summary
Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.
The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •AHI ≥ 5 from the diagnostic night
- •≥ 18 years of age
- •Either prescribed APAP or CPAP or Bi level for OSA
- •Existing full face users
Exclusion Criteria
- •Inability to give informed consent
- •Participant intolerance to PAP
- •Anatomical or physiological conditions making PAP therapy inappropriate
- •Current diagnosis of respiratory disease or CO2 retention
- •Pregnant or think they may be pregnant
Outcomes
Primary Outcomes
The mask is comfortable and is effective for the participant during in-home use
Time Frame: 1 week for each mask prototype in-home
Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data.
Secondary Outcomes
- Acceptability of the Full Face mask prototypes(1 week for each mask prototype in-home)