Obstructive Sleep Apnea, Sleep Disordered Breathing
Conditions
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.
Interventions
DEVICEF&P Interface
F&P Interface to be used for OSA therapy
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trial Mask usability | 14 ± 4 days in home | Questionnaire on ease-of-use (very easy to very difficult) Subjective |
| Trial mask Performance | 14 ± 4 days in home | Questionnaire on performance (very good to very poor)- Subjective |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trial mask Reliability | 5 months and 2 weeks in home | Questionnaire on reliability - Subjective |
| Trial mask performance measured in L/min | 14 ± 4 days in home | Objective leak data from PAP device |
Countries
New Zealand
Outcome results
None listed