The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 6
- Primary Endpoint
- Trial Mask usability
Study Overview
Brief Summary
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.
Detailed Description
A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.
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
- •Adult (18+ years of age)
- •Able to give written consent
- •AHI ≥ 5 on diagnostic night
- •Either prescribed APAP, CPAP or Bi-level PAP for OSA
Exclusion Criteria
- •Inability to give written consent
- •Anatomical or physiological conditions making PAP therapy inappropriate
- •Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- •Current diagnosis of respiratory disease or CO2 retention
- •Pregnant or may think they are pregnant.
Outcomes
Primary Outcomes
Trial Mask usability
Time Frame: 14 ± 4 days in home
Questionnaire on ease-of-use (very easy to very difficult) Subjective
Trial mask Performance
Time Frame: 14 ± 4 days in home
Questionnaire on performance (very good to very poor)- Subjective
Secondary Outcomes
- Trial mask Reliability(5 months and 2 weeks in home)
- Trial mask performance measured in L/min(14 ± 4 days in home)